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.
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: 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
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
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.
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