FDA issues Class I recall on GE Carestations due to ventilation issue
In what is being referred to as a recall, the U.S. Food and Drug Administration (FDA) released a notice on behalf of GE HealthCare for a line of its Carestations due to a risk the ventilation systems may not work properly. Despite the serious risk of death or injury caused by inadequate respiration, the problem has been isolated and can be fixed with updated use instructions.
Although no devices have been removed from care settings, this recall has been designated a Class I by the FDA, reserved for the most serious issues. Luckily, no injuries or deaths have been reported.
The systems are typically used to aid with anesthesia in patients of all ages. They can be found in many hospitals and surgery centers across the country.
The diminished ventilation issue stems from when “Volume Control Ventilation” is active on the Carestations, though pressure control modes will still work properly. If the error occurs, the FDA said it will be “apparent to the user through observation and multiple alarms.”
Specifically, the inflated bellows will noticeably stop moving and an alarm will alert users to a problem. The various alerts that could signal that a patient isn’t receiving adequate ventilation should all be working properly, as they are not a part of this recall notice.
The devices impacted by this notice are the Carestation 620/650/650c and 750/750c Anesthesia Systems, of all serial numbers and lots.
Next Steps
To safely use the Carestations, GE HealthCare has issued corrected instructions for operation. The details were sent to known customers on March 21, and are summarized below:
- Ensure users are made aware not to use “Volume Control Ventilation (VCV)” mode, until the devices are tested for safety.
- Perform a ventilation screening test on each affected Carestation system. If the test is successful, the devices may be used as normal. If it fails, then only pressure controlled ventilation can be safely used. VCV will need to be fixed by a GE HealthCare technician.
The FDA and the company are asking that anyone in possession of one of the recalled systems return a Medical Device Notification Acknowledgement Response Form. This will be used to initiate a repair from GE HealthCare. For more details, contact the company for service at 1-800-437-1171.
It’s also asked that this notice be posted near all impacted Carestation devices. The full recall alert can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.