FDAJuly 20, 2022device

Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.

What to do

FDA enforcement status: Ongoing

Brands named

getinge usa salesgetingegetinge usa

UPCs

73257100031183

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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