Reported Feb 1, 2023 · Ongoing
Getinge Flow-c Anesthesia System, Part No. 6887700
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?
- Getinge Flow-c Anesthesia System, Part No. 6887700
- Lot codes and dates
- Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
- Amount recalled
- 8.016 Total (7.766 OUS; 250 US)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
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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