Maquet Cardiovascular Us Sales, Llc recalls Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation ane…

Recall date

December 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0804-2016

FDA classification

Class I

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

US Nationwide in the states of CA, NY, and OR

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.