GE Healthcare has recalled 4,222 Carescape R860 ventilator backup batteries in a class 1 recall, the most serious type, after discovering replacement batteries were unexpectedly running out of juice.
The alert notified users that if replacement batteries fail, the device will stop producing oxygen, which can lead to serious injury or death. The Chicago-based manufacturer has noted 1,553 complaints, no injuries and no deaths related to the recall.
The FDA recommends customers perform a battery performance test and continue using the ventilators while "connected to an AC mains power source that is supported by backup emergency power."