Reported Mar 2, 2016 · Terminated
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation…
Maquet Cardiovascular US Sales, LLC
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: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- Flow-i Anesthesia System Product UsageThe indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration
- Lot codes and dates
- Model numbers
C20C30 and C40 (Only Model #
- C20 for US) Part numbers
66 77 200 (US Only)66 77 300 and 66 77 400 Serial numbers (274328522854285528562858
- Model numbers
- Amount recalled
- 7 units within US
Where it was sold
Why it was recalled
Stop using this product now
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
Using this product could cause serious injury, illness or death — stop using it now.
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