Z-0961-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2023
- Initiation Date
- December 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8.016 Total (7.766 OUS; 250 US)
Product Description
Getinge Flow-e Anesthesia System, Part No. 6887900
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 Pattern
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 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.