Reported Feb 1, 2023 · Ongoing
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
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-i Anesthesia Systems Flow-i C20Part no. 6677200 Flow-i C30Part no. 6677300 Flow-i C40Part no. 6677400
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 66772007325710001349Serial Numbers 1202-8027 Part # UDI 66773007325710001363Serial Numbers 1058-1201 Part # UDI 66774007325710001318Serial Numbers 2034-8446 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Getinge USA Sales Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.