Getinge recalls Flow-e Anesthesia Systems with serial numbers 50012-50132 due to potential crack in suction switch that could prevent suction activation during surgery.
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Getinge is recalling Flow-e Anesthesia Systems with specific serial numbers because a crack in the suction switch might prevent the device from working during surgery. This could lead to serious harm if the patient needs suction assistance.
The suction unit's on/off switch can crack, potentially breaking the switch and preventing the suction unit from activating. This could cause the device to stop working during critical medical procedures like surgery, where suction is needed to clear airways.
Healthcare professionals using the Flow-e Anesthesia System for patient anesthesia are most at risk. Patients undergoing surgery with this device could be affected if the suction unit fails.
Check the serial numbers listed: 50012 through 50132. The product was sold by Getinge Usa Sales Inc and the UDI-DI was corrected on July 7, 2022.
Verify your Flow-e Anesthesia System's serial number against the list: 50012-50132.
Reach out to Getinge Usa Sales Inc for further instructions or to confirm if your device is affected.
The device may have a crack in the suction switch that could prevent it from working during surgery. Do not use it until you confirm it's safe.
Check the serial number against the list: 50012 through 50132. The product was sold by Getinge Usa Sales Inc.
Contact Getinge Usa Sales Inc to confirm if your device is affected and get instructions.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2022 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-1279-2022 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.
