Company: Getinge Usa Sales Inc
Date of Enforcement Report: 1/26/2023
Class I
PRODUCT
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Programmable Diagnostic Computer
Recall Number:
Z-0959-2023
REASON
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.
RECALLING FIRM/MANUFACTURER
Getinge Usa Sales Inc
VOLUME OF PRODUCT IN COMMERCE
8,016 Total (7,766 OUS; 250 US)
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.
