Getinge recalls Flow-e Anesthesia System (part 688: 07325710010457) due to software bug causing ventilation failure. Affected units may not build pressure, risking oxygen shortage.
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Getinge is recalling its Flow-e Anesthesia System with specific software versions because a bug can prevent proper ventilation. This could lead to oxygen shortages during surgery, putting patients at risk.
A software bug in the system prevents building up pressure under certain conditions. This can cause the system to stop delivering oxygen, leading to hypoventilation and hypoxia if gas delivery is interrupted.
Anesthesia providers using the Flow-e system with software versions 4.8.0 through 4.8.3 are affected. Patients undergoing surgery are at risk if the system fails to maintain oxygen levels.
Check for part number 6887900 with serial numbers 50012-50197 and software versions 4.8.0 to 4.8.3. The system was sold with specific UDI codes.
Verify your system's software version is 4.8.0 to 4.8.3 to confirm if it's affected.
If you have the affected software, ensure oxygen delivery is maintained during use to prevent hypoventilation.
Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Check for part number 6887900 with serial numbers 50012-50197 and software versions 4.8.0 to 4.8.3.
Monitor oxygen levels closely and ensure the system maintains proper ventilation to prevent hypoventilation.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-0961-2023 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-0961-2023 from Getinge. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
