Gentherm recalls Hemotherm 400CE (catalogs 86022/86023) due to potential control panel switch errors causing unintended temperature changes during blood cooling procedures.
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Gentherm is recalling Hemotherm 400CE dual reservoir coolers/heaters because their control panel switches might malfunction, causing unintended temperature changes during blood cooling procedures. This could affect patient safety during surgeries requiring blood temperature control.
The device's control panel switches may malfunction, causing unintended changes to temperature settings. This could lead to improper blood temperature during critical surgical procedures, potentially affecting patient safety.
Medical professionals using the Hemotherm 400CE during cardiopulmonary bypass surgeries lasting six hours or less. Patients receiving blood temperature control during surgery are at risk if the device malfunctions.
Check for catalog numbers 86022 or 86023 on the Hemotherm 400CE device. The product is used during cardiopulmonary bypass surgeries lasting six hours or less.
Verify that the control panel settings appear correct and stable before use.
The Hemotherm 400CE with catalog numbers 86022 or 86023.
No, this device is only used in medical settings during cardiopulmonary bypass surgeries lasting six hours or less.
Check the control panel settings to ensure they are stable and correct before use. No immediate action is required beyond this check.
We’ve drafted a message you can send Gentherm to request your refund or repair — edit it as you like.
Subject: Recall Z-0063-2019 — Gentherm Gentherm Hello, I own a Gentherm that is covered by recall Z-0063-2019 from Gentherm. 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.
