GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

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.

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.

See FDA link for more details: https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-carescape-respiratory-modules-due-incorrect-oxygen-values?utm_campaign=2020-02-04%20GE%20Healthcare%20Recalls%20CARESCAPE%20Respiratory%20Modules&utm_medium=email&utm_source=Eloqua