Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Fl...
FDA Recall #Z-0959-2023 — Class I — December 22, 2022
Product Description
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
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.
Recalling Firm
Getinge Usa Sales Inc — Wayne, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
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.
Code Information
Part # UDI 6677200 7325710001349 Serial Numbers 1202-8027 Part # UDI 6677300 7325710001363 Serial Numbers 1058-1201 Part # UDI 6677400 7325710001318 Serial Numbers 2034-8446 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated