Getinge Usa Sales Inc: 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.

Agency Publication Date: January 26, 2023

Affected Products

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

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.

Product: Getinge Flow-c Anesthesia System, Part No. 6887700

Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.

Product: Getinge Flow-e Anesthesia System, Part No. 6887900

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91339

Status: Active

Manufacturer: Getinge Usa Sales Inc

Manufactured In: United States

Units Affected: 3 products (8,016 Total (7,766 OUS; 250 US); 8.016 Total (7.766 OUS; 250 US); 8.016 Total (7.766 OUS; 250 US))

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Sources: FDA iRES · Raw API Response

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