The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

Related recalls

Same category