Getinge recalls Flow-i C20, C30, and C40 anesthesia systems with software versions 4.8.0-4.8.3 due to a bug that can prevent oxygen delivery, risking hypoxia.
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-i C20, C30, and C40 anesthesia systems because a software bug can cause the device to fail to build pressure, leading to no ventilation and potential oxygen shortage. This could cause serious health risks during anesthesia procedures.
A software bug in the device can prevent it from building pressure under certain conditions, causing no ventilation. If gas delivery stops, oxygen levels may drop significantly, leading to hypoxia (low oxygen) and potentially serious health issues during anesthesia.
Anesthesia providers using the Flow-i C20, C30, or C40 models with software versions 4.8.0 through 4.8.3 are affected. Patients undergoing surgery with these systems face the highest risk.
Check for the Flow-i C20 (part # 6677200), C30 (part # 6677300), or C40 (part # 6677400) with software versions 4.8.0, 4.8.1, 4.8.2, or 4.8.3. Serial numbers are listed in the recall notice.
Review the software version on your device to confirm if it is 4.8.0 through 4.8.3.
Reach out to Getinge for guidance on next steps if your device is affected.
Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Check the part number and software version on your device; affected models are Flow-i C20 (part # 6677200), C30 (part # 6677300), or C40 (part # 6677400) with the listed software versions.
Contact Getinge for guidance on next steps; the recall does not include a specific fix or replacement.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-0959-2023 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-0959-2023 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.
