Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Recalled by Maquet Cardiovascular Us Sales, Llc Due to Electrical issues in the control, monitoring or panel...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.
Affected Products
Flow-i Anesthesia System Product Usage: The 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.
Quantity: 7 units within US
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report