Getinge Usa Sales Inc: Getinge Flow-e Anesthesia System, Part No. 6887900

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 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.

UPC codes

07325710010457

Source

Official record: FDA (Device enforcement) ↗

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