FDA recall Z-0960-2023

Getinge Usa Sales Inc · Class I · device

Product

Getinge Flow-c Anesthesia System, Part No. 6887700

Reason for recall

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.

Distribution

US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.

Key facts

Status
Ongoing
Initiation date
2022-12-22
Report date
2023-02-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2023