Getinge recalls anesthesia system with software bug that prevents pressure buildup, risking oxygen shortage during surgery. Affected units have specific serial numbers and software versions.
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-c Anesthesia System due to a software bug that can prevent proper pressure buildup, leading to no ventilation and potential oxygen shortage. This could cause hypoxia if gas delivery stops during surgery.
The software bug prevents the system from building pressure under certain conditions, which stops ventilation. If gas delivery stops, oxygen levels drop, potentially causing hypoxia (low oxygen) and hypoventilation (inadequate breathing) during surgery.
Surgical staff and patients using the Getinge Flow-c Anesthesia System with the specific serial numbers and software versions listed in the recall notice are affected. Patients at risk during anesthesia procedures are most vulnerable.
Check for serial numbers between 4003-5078 and software versions 4.8.0 through 4.8.3 on the Getinge Flow-c Anesthesia System. The recall covers specific units sold with these identifiers.
Verify the software version on your device; affected units have versions 4.8.0 to 4.8.3.
Reach out to Getinge Usa Sales Inc for guidance on next steps if your device is affected.
Yes, the software bug can cause no ventilation and oxygen shortage during surgery, potentially leading to hypoxia.
Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3 are affected.
Check the serial number (4003-5078) and software version on your Getinge Flow-c Anesthesia System.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-0960-2023 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-0960-2023 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.
