Agency classClass IOur severity:Severe FDA (Devices)·Z-0959-2023·Announced 2023-02-01

Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect

Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall for a medical device that can fail to deliver ventilation during anesthesia, creating risk of hypoxia. Although no illnesses or deaths have been reported, FDA Class I classification establishes a minimum severity of Severe (4) per the rubric.

Plain-English summary

Getinge USA Sales Inc. is recalling the Getinge Flow-i Anesthesia Systems (models C20, C30, and C40) due to a software bug in system versions 4.8.0 through 4.8.3. The software can prevent pressure buildup under certain conditions, resulting in no ventilation delivery. Additionally, if gas delivery is interrupted, there may be a sustained decrease in delivered oxygen concentration, which may lead to hypoventilation and hypoxia.

The recall affects 8,016 units distributed worldwide, including 250 units in the United States. Domestic distribution includes healthcare facilities in Alabama, Arizona, Arkansas, California, Colorado, DC, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia. Affected equipment can be identified by part numbers 6677200 (C20), 6677300 (C30), 6677400 (C40), and serial number ranges provided by the manufacturer.

Healthcare facilities and anesthesia providers should immediately identify affected systems using the serial number ranges and software version information provided in the recall and contact Getinge USA Sales Inc. for guidance on remediation or replacement.

The recalled product

Product: Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Anesthesia System
Hazard: software-defect
ventilation-failure
hypoxia-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

4.8.1
4.8.2
and 4.8.3.

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

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