The Recall Desk
SevereFDA (Devices)·Z-0960-2023·Announced 2023-02-01

Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation

The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.

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: FDA Class I classification requires a minimum severity score of 4. The software bug can prevent ventilation and oxygen delivery in an anesthesia system, creating serious patient safety risk. No deaths or hospitalizations are reported in the source material.

Plain-English summary

Getinge is recalling the Flow-c Anesthesia System (Part No. 6887700) due to a software bug in versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3. The bug prevents pressure from building up under certain conditions, which can result in no ventilation delivery. If gas delivery is stopped, a sustained decrease in delivered oxygen concentration may lead to hypoventilation and hypoxia.

8,016 units have been distributed worldwide, including 250 units within the United States across multiple states (AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV). Affected serial numbers range from 4003 to 5078.

The recalled product

Product
Getinge Flow-c Anesthesia System, Part No. 6887700
Manufacturer
Getinge Usa Sales Inc
Category
Medical Device — Anesthesia Equipment
Hazard
  • software-bug
  • ventilation-failure
  • oxygen-delivery-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