FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

AVEA Ventilator is Recalled Due to an Electrical Issue

Aug. 1, 2016

CareFusion is recalling its AVEA ventilator due to a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down.

The FDA has identified this as a Class I recall because the product’s use can have serious, even fatal, consequences. If the ventilator shuts down, a patient may not receive adequate oxygen.

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