Getinge Usa Sales Inc: Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

Hazard

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.

Details from the source

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. Quantity: 8,016 Total (7,766 OUS; 250 US) Lot/code info: 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.

UPC codes

7325710001349, 7325710001363, 7325710001318

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.