MedWrench FDA Alerts


Please sign in to Subscribe to FDA Alerts

Image: Class 1 Recall: FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication

Fuji informed the Agency of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use....

Image: Class 1 Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial

Bayer has determined all Source Administration Sets used with the Medrad Intego PET Infusion System may produce a particulate matter in the medicine vials....

Image: Class 1 Recall: Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication

Many medical devices—including St. Jude Medical's implantable cardiac devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits....

Image: Class 1 Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections

Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems....

Image: Class 1 Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization

Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case....

Image: Class 1 Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate

Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process....

Image: Class 1 Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Medtronic is recalling of certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters....

Image: Class 1 Recall: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate from the packaging and potentially cause serious injuries to patients....

Image: Class 1 Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connectors which may Prevent Alarm from Sounding and Pump Stops

HeartWare Inc. is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump's driveline connector to become separated from the front portion of the driveline connector....

Image: Class 1 Recall: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source....

Image: Class 1 Recall: St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion

St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium, forming within the battery, and causing a short circuit....

Image: Class 1 Recall: TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use

Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient....

Image: Class 1 Recall: Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10

The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed....

Image: Class 1 Recall: UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) St?ckert 3T Heater-Cooler System: FDA Safety Communication

The FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries....

Image: Class 1 Recall: Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication

FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected....

Image: Class 1 Recall: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination

Baxter Corp. is recalling the 50 mm 0.2 Micron Filter after receiving reports about the presence of particulate matter and the potential absence of filter membrane layers in the filter set....

Image: Class 1 Recall: DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk

DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode....

Image: Class 1 Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination

Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide recalled certain lots of material because of a potential contamination by glass particles....

Image: Class 1 Recall: Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication

Sciex notified the FDA that, under certain conditions, the defect in the software versions identified above may lead the devices to display results that do not match the specimens tested....

Image: Class 1 Recall: Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results

Under certain conditions, the INRatio System may generate an incorrect low result; an INR result that is lower than the result expected using a plasma-based laboratory INR method....

Image: Class 1 Recall: FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Communication

The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 URGENT MEDICAL DEVICE RECALLdisclaimer icon, and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes....

Image: Class 1 Recall: BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction

BioMerieux is recalling the NucliSENS® easyMAG® Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance....

Image: Class 1 Recall: Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage

The firm discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels....

Image: Class 1 Recall: Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage

The firm discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels....

Image: Class 1 Recall: CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown

CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down....

CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down....

Image: Class 1 Recall: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation

Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions), is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body....

Image: Class 1 Recall: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion

HeartWare Inc. is recalling the batteries because they may lose power prematurely due to faulty cells....

Image: Class 1 Recall: Mycobacterium chimaera Infections Associated with Sorin Group Deustchland GmbH Stickert 3T Heater-Cooler System: FDA Safety Communication

The FDA is providing new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in patients who have undergone cardiothoracic surgeries....

Image: Class 1 Recall: Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect

Hummingbird Med Devices Inc. is recalling the Hummi Micro-Draw Blood Transfer Device because the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use....

Image: Class 1 Recall: Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk

Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the system monitor....

Image: Class 1 Recall: B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors

B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood....

Image: Class 1 Recall: Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage

Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures....

Image: Class 1 Recall: Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results

Focus Diagnostics is recalling Simplexa™ Herpes Simplex Virus 1 & 2 Direct and Simplexa™ Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells....

Image: Class 1 Recall: Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect

Vascular Solutions is recalling the Guardian II Hemostasis Valve because of a defect in the low pressure seal, which may allow air bubbles into the device and block blood supply to the heart or blood vessels (air embolism)....

Image: Class 1 Recall: Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure

Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected....

Image: Class 1 Recall: Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate

Cook Medical is recalling these devices because the tips may split or separate from the catheters due to a manufacturing error....

Image: Class 1 Recall: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue

Arrow International Inc. is recalling the Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits because the sheath body may separate from the sheath hub during the insertion procedure....

Image: Class 1 Recall: Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption

Verathon Incorporated is recalling the GlideScope Titanium Single-Use Video Laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor....

Image: Class 1 Recall: Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process

Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system....

Image: Class 1 Recall: Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication

Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling....

Image: Class 1 Recall: Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware

Dräger Medical expanded its December 2015 recall to include the PS500 Optional Power Supply units that were updated with new software as part of the December recall....

Image: Class 1 Recall: Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots

Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter to include additional product lots. The recall now affects 408,011 total catheters distributed in the US....

Image: Class 1 Recall: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order....

Image: Class 1 Recall: Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication

From January 2009 to January 2016, the FDA received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries....

Image: Class 1 Recall: PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication

PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling....

Image: Class 1 Recall: Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy

Dräger is recalling the Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used....

Image: Class 1 Recall: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy

Brainlab is recalling the Cranial IGS System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy....

Image: Class 1 Recall: Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets - Catheter May Break During Insertion

Stryker Sustainability Solutions received two reports that the catheter included in the Drainage Set broke off in the pleural cavity while inserting the device into the patient....

Image: Class 1 Recall: Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly

Dräger is recalling the PS500 battery power supply because a software issue causes shorter than expected battery run times....

Image: Class 1 Recall: The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication

The FDA is warning health care providers and staff at health care facilities not to use Customed convenience packs and trays for any surgical procedures....

Image: Class 1 Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure

Class 1 Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure...

Image: Class 1 Recall: Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working

Class 1 Recall: Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working...

Image: Class 1 Recall: FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication

Class 1 Recall: FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication...

Image: Class 1 Recall: Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin

Class 1 Recall: Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin...

Image: Class 1 Recall: Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication

Class 1 Recall: Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication...

Image: Class 1 Recall: Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death....

Class 1 Recall: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death....

In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its AERs from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and...

Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication...

Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication...

Class 1 Recall: Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System...

The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose....

Class 1 Recall: HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls...

Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch - May Cause Blood Clots...

Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication...

Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes...

This recall was updated on January 8, 2015....

A recall has been issued for Heart Sync, Multi-function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs. Philips made changes to the connector design of their FR3 and FRx AEDs, and because of these changes, the...

Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs....

A recall has been issued for the Nellcor Puritan Bennett, 980 Ventilator System. Part of the circuit board may have cracks due to problems in this manufacturing process. The cracks can cause the ventilator’s display screen to dim and give off a...

Puritan Bennett 980 Ventilator Systems with software versions below 2.8 may have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected....

The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits....

The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it....

Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps....

CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because it may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used....

The firm received 106 reports of device malfunctions. There were zero injuries and one death....

The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly....

There is a potentially defective component on the Trilogy Ventilator power management board which could affect the function of the device....

The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical...

Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) - Erroneously Low Blood Glucose Results...

The firm received customer reports of two potential malfunctions that may occur with the GemStar Docking Station. To date, there have been no reports of death or serious injury associated with these malfunctions....

  Recall Class: Class I Date Recall Initiated: February 7, 2014 Products: Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB Affected products were manufactured from July 1, 2005...

Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion...

The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used....

The FDA is alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency....

here is a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00....

Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly......

The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels....

The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation....

The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required....

The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required....

The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during...

Battery modules allow device users a possibility to operate the SERVO-i ventilator during intra-hospital transportation....

he Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump....

These products are used in the hospital environment and in locations not requiring mobility of the products....

The HAMILTON-T1 ventilator provides continuous or intermittent breathing support to adults and pediatric patients....

The Giraffe OmniBed can function as an incubator (closed mode) or as a warmer (open mode) and can transition from one mode to the other on the user’s demand. Incubators and warmers are used to maintain the body temperature of a newborn baby....

The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for...

The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. Certain Samaritan® 300/300P PAD devices have been found to intermittently turn on and off,...

The affected anesthesia delivery systems may have a gasket leak which could cause an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death....

Baxter Healthcare Corporation (Baxter) has initiated a voluntary recall of its Automix Compounder (Automix) because of incorrect key press responses, caused by fluid entry into device keypads, and intermittent electrical failures. Fluids, such as...

A component on the PC unit power supply board is causing an error code (120.4630): "System Error" or "Missing Battery Error" to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC...

The firm determined that the ON-Q pumps with ONDEMAND bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position. When this occurs, the patient may receive continuous...

The Trilogy 100, 200, and 202 ventilators are being recalled because power supply components may be defective in some cases. If a ventilator’s power supply fails, the ventilator may unexpectedly stop functioning, thereby...

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets...

This is an expansion of a previous recall, initiated by B. Braun in January, 2012, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch...

GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. Download...

System errors can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. For patients receiving critical therapy, such as vasopressors, a delay or...

The affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences, including death. The...

CareFusion has identified potential defects associated with the EnVe Ventilator model 19250-001 that can interrupt ventilation to the patient. Download...

Nemschoff Chairs, Inc. initiated a recall to correct issues with the wheels (casters), door hinges and drawer slides on the cart’s frame and the acrylic bassinet tub. Also, the manufacturer added labeling to the products regarding drawer...

Philips OmniDiagnost Eleva Failure Causing Generator to Stop Working. A short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator. In exceptional cases if this occurs the generator stops...

CareFusion is recalling these affected devices and software for two reasons: The device’s software incorrectly indicates stimulation is delivered to a different electrode than the one selected A short circuit may develop...

The recalled cable may cause an electrical shortage that can cause Newport HT50 ventilators manufactured prior to 2007 to shutdown unexpectedly. Download...

Based on additional analyses since the initial recall, SIGMA expanded their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above. These units may fail suddenly...

Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmol/L. Use of this product may lead to...

Steris System 1 Processor: 6 Month Extension for Healthcare Facilities To Transition to Legally-Marketed Alternatives. FDA has extended the transition period to February 2, 2012. All healthcare facilities must be transitioned from Steris...

Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can...

AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. Download...

There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. Download...

Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously. Download...

Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. Download...

Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. Download...

GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the...

Failure to properly document the CTDI in the Technical Reference or User Manual. Download...

GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact...

Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. Download...

A defect with the hardware and software displaying the incorrect dose data. Download...

Pocket fills (the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose. Download...

There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly. Download...

Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field. Download...

Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact. Download...

The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch. Download...

The system may deliver an inaccurate dose that does not match the treatment plan....

Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue. Download...

GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems. Download...

Important safety and disclosure information for professional users and consumers of the PhysioControl LifePak line of Defibrillators and AED's....

Infusion systems upgraded with the Motorola compact flash hardware and supporting software when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication can potentially induce a memory leak that can cause the...

In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. Download...

Potential for bright artifacts to appear on the patient image from a previous exposure....

Smiths Medical announced that it is voluntarily initiating a global recall of Medfusion® Syringe Infusion Pumps, Models 3010a and 3500, manufactured from August 2008 to June 10, 2009....

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating...

Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."...

The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit....

MedWrench is in association with:

LabWrench TechNation Medical Dealer OR Today MD Expo LabX