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  5. GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values
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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.

Recalled Product

Device Use

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.

Contact Information

Customers who have questions regarding this notification should contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Additional Resources

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.