U.S. FDA Classifies Recall of GE’s Ventilator Batteries as Most Serious

U.S. health regulators on Tuesday classified the recall of some backup batteries of GE Healthcare’s ventilators, which the company had initiated in mid-April, as the most serious type, saying that their use could lead to injuries or death.

The CARESCAPE R860 ventilator’s backup batteries, including replacement backup batteries, were recalled as they were running out earlier-than-expected, which could cause the device to shut down preventing the patient from receiving breathing support, the U.S. Food and Drug Administration said.

The CARESCAPE R860 ventilators use the main power via a wall plug to operate and the device’s backup battery is meant to keep it running in situations such as patient transport. read more