FDA Provides Update on GE Healthcare’s Recall of Ventilator Batteries

The FDA has issued an update on GE Healthcare’s April 18 recall of back-up batteries for certain of its ventilators, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is that the alarm that alerts the user about battery run time remaining may be inaccurate. That problem could result in the ventilator shutting down sooner than indicated by the alarm when running on the backup battery, which could potentially lead to loss of ventilation for the patient.

The batteries are for GE Healthcare’s Carescape R860, Engström Carestation and Engström PRO devices. More than 100,000 affected batteries were distributed on or after April 1, 2019.

There have been no reported injuries or deaths linked to the problem, the agency said.