FDA (Devices) recall action 90076
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.
GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.