Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Reported: February 1, 2023 Initiated: December 22, 2022 #Z-0959-2023
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.
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400. Recalled by Getinge Usa Sales Inc. Units affected: 8,016 Total (7,766 OUS; 250 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2023. Severity: Critical. Recall number: Z-0959-2023.
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