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.
GE Healthcare, the medical device making arm of General Electric (GE.N), had initiated the recall of 4,222 of its ventilator batteries distributed between April 2, 2019, and April 18, 2022.
There have been 1,553 complaints and no injuries associated with the use of the device, the FDA said.
On Tuesday, Philips (PHG.AS) said independent tests on ventilators that the Dutch company recalled last year because of possible health risks showed the problems were almost exclusively caused by unauthorized cleaning products.
The Amsterdam-based company’s recall was launched amid concerns that a type of foam used in the devices could deteriorate and become toxic.