Reported Aug 31, 2022 · Ongoing
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number…
Getinge USA Sales Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035
Is this the product you have?
- Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part
- Number 6688600 Servo-u MR ventilatorPart
- Number 6888800 Servo-airPart Number 6882000
- Lot codes and dates
- UDI-DIServo-air: 73257100031183 Servo-u, Servo-n
- Servo-u MR7325710001117R
- Serial Numbers
5,456 of 5,456 codes
4638546685466974684134174670246703467044670546824468264682746828465584655946560465614656346564465654656646562465574658046337465764657746578465794657446575464784647946572465734645446460464614646246463464644646546466464684646746469464704647146472464734647446475464764647733973398339924534183420
- Amount recalled
- 37000 (11089 US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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