26
Jan
2023

Recall: Software Bug Can Lead to Hypoventilation and Hypoxia

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Company: Getinge Usa Sales Inc
Date of Enforcement Report: 1/26/2023
Class I

PRODUCT

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

Programmable Diagnostic Computer

Recall Number:

Z-0959-2023

REASON

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/MANUFACTURER

Getinge Usa Sales Inc

VOLUME OF PRODUCT IN COMMERCE

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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