The Recall Desk
SevereFDA (Devices)·Z-0961-2023·Announced 2023-02-01

Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation

Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia 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: FDA classified this as a Class I recall. The rubric requires Class I recalls score at minimum 4 (Severe). The software defect creates significant risk of patient harm through inability to deliver oxygen and ventilation during anesthesia, but no deaths or serious injuries are explicitly reported in the source.

Plain-English summary

Getinge Usa Sales Inc is recalling the Getinge Flow-e Anesthesia System (Part No. 6887900) due to a software defect affecting certain firmware versions.

The system has a software bug that, under certain conditions, prevents pressure buildup in the anesthesia delivery circuit. This can result in no ventilation delivery to the patient. Additionally, if gas delivery is interrupted, oxygen concentration may decrease significantly, leading to hypoventilation and hypoxia—serious conditions for anesthesia patients.

Affected units include approximately 250 systems distributed in 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), with additional units distributed worldwide. Serial numbers 50012-50197 are affected, specifically those running software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.

Hospitals and medical facilities operating these systems should immediately cease use of affected units and contact Getinge for guidance. Healthcare providers should verify their equipment serial numbers and software versions against the provided identifiers. Do not resume operation until advised by Getinge or the FDA.

The recalled product

Product
Getinge Flow-e Anesthesia System, Part No. 6887900
Manufacturer
Getinge Usa Sales Inc
Category
Medical Device — Anesthesia Equipment
Hazard
  • software-defect
  • ventilation-failure
  • hypoxia

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