Medical Equipment Alerts and Notices

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 example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.

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, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.

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 water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.

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 unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.

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 infusion at a rate greater than expected. As a result, this product may cause serious adverse health consequences, including death.

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 stopping ventilation. The ventilator alarm may also fail to sound. Ventilator power supply failures can result in serious adverse health consequences, including death.

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 is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.

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.

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 interruption of therapy could result in serious injury and/or death. According to the firm, there have been no reports of patient injury or death due to this problem.

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 unit’s self test may not detect the failure or impending failure of the component.

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

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 weight limits, and specific instructions for cleaning the bassinet tub. This product may cause serious adverse health consequences, including death.

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 between the cortical stimulator control unit and the stimulus switching unit amplifier

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

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 causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

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 inappropriate patient treatment and may cause serious adverse health consequences, including death.

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 Corporation’s modified System 1 processor (SS1) to legally-marketed alternative devices by that time.

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 disengage due to the lack of thread locker on set screws.

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.

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.

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

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

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

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.

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

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 AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected.

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

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 service or maintenance personnels safety

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 service or maintenance personnels safety.

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 service or maintenance personnel's safety.

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.

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

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.

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.

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.

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

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.

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.

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

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.

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 working.

GE Healthcare has become aware of a change in the design of a component associated with the snubber board of the OEC 9800 C-Arm and 9900 C-arm that may impact patient safety.

HemoCue Glucose 201DM Software May Have Incorrect Configuation Settings, Error Codes

Medtronic 5388 External Temporary Pulse Generator May Be Unable to Power Up or May Power Down Unexpectedly.

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

Earth Leakage in a Single Fault Condition May Exceed the Allowable Current Limit. Recent tests have identified that under certain conditions the earth leakage, in a single fault condition, can be up to 6.8 mA which is above the allowable limit of 3.5mA.

Terumo Cardiovascular Systems (Terumo CVS) has received reports of premature failure of the oxygen sensor in the electronic gas blender of the Terumo Advanced Perfusion System 1.

Electrocardiograph-Gated Dynamic Volume Prospective Scan May Cease Unexpectedly

Philips has received reports that Philips gas analyzers, models M1013A and M1019A, may display an unusually high sample flow rate which may result in additional technical alarms (INOP's) and in the display of a question mark <-?-> instead of the numerics of the measured gases.

Misusing Localized Heat Therapy for ECMO.

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 Management Processor to become non-responsive.

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

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

Valves May Fail Prematurely, Potentially Leading to Erroneous Results, Increased Instrument Errors, and/or Fluid Leaks

Package Insert May Contain Incorrect Acceptable Performance Range.

Potential for unrestricted flow if cassette is removed before the cassette carriage fully opens and the slide/roller clamp is not closed.

The PTCA catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.

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 that three minutes are left before the X-ray is inhibited.

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 that three minutes are left before the X-ray is inhibited.

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 that three minutes are left before the X-ray is inhibited.

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 that three minutes are left before the X-ray is inhibited.

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 reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly during manufacturing.