GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values
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.
Tue Feb 04 2020
- Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302)
- Serial numbers:
- Airway Gas Option N-CAiO Serial Numbers
- CARESCAPE Respiratory Module E-sCO Serial Numbers
- CARESCAPE Respiratory Module E-sCOVX Serial Numbers
- CARESCAPE Respiratory Module E-sCAiO Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOV Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOE Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOVE Serial Numbers
- Manufacturing Dates: June 7, 2019 to August 16, 2019
- Distribution Dates: June 7, 2019 to August 16, 2019
- Devices Recalled in the U.S.: 165
- Date Initiated by Firm: September 27, 2019
The GE Healthcare CARESCAPE Respiratory Modules and Airway Gas Option are respiratory accessories designed for use with patient monitors and ventilators to measure respiratory gases (such as oxygen and carbon dioxide), anesthesia, and breathing characteristics in adults, pediatric, and neonatal patients.
The affected modules can be used with other GE Healthcare monitoring equipment.
Reason for Recall
GE Healthcare is recalling the CARESCAPE Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values which could lead to high (hyperoxia) or low (hypoxia) blood oxygen levels in the patient.
The use of the affected product may cause long-term high or low blood oxygen levels, which could result in organ damage, tissue injury, increased chance of infection, or death.
There have been no reported injuries or deaths.
Who May be Affected
- Health care providers using the GE Healthcare CARESCAPE Respiratory Modules and Airway Gas Option monitoring equipment
- Patients receiving treatment with the GE Healthcare CARESCAPE Respiratory Modules and Airway Gas Option monitoring equipment
What to Do
On September 27, 2019, GE Healthcare sent a letter to customers informing them of the affected models and provided the following instructions:
- Replace the affected respiratory modules with another module that is not affected by the issue. GE Healthcare will provide a replacement at no cost.
- Ensure that respiratory modules are within specification, if they don't have a replacement, following the provided safety instructions.
- Complete the provided form and return the form to GE Healthcare within 30 days from receipt.
Additionally, the FDA is informing customers to be aware that the modules can deteriorate over time. Customers should check that the modules are within specification using the provided instructions on at least a daily basis.
Customers who have questions regarding this notification should contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
- Medical Device Recall Database Entries:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.