Belmont Instrument Corporation recalls CritiCool thermoregulation devices with serial numbers starting with 99... due to premature pump failure causing HALT 4 error and potential delayed therapy. One death reported.
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Belmont Instrument Corporation is recalling CritiCool thermoregulation devices that may display a HALT 4 error and fail to recover after reboot, risking delayed treatment. One death has been reported potentially linked to this issue.
The device's pump may fail prematurely, causing it to display a HALT 4 error that cannot be resolved through reboot. This can lead to the device failing to deliver prescribed thermoregulation therapy, potentially causing delayed treatment and serious health consequences.
Users of CritiCool thermoregulation devices with specific serial numbers (listed in the recall) who rely on the device for medical therapy. Patients with critical temperature regulation needs are most at risk.
Check if your CritiCool device has a serial number starting with '99' followed by 12 digits (e.g., 9978580900011). The full list of affected serial numbers is provided in the recall notice.
Look for a HALT 4 error message on the device display. If present, stop using the device immediately.
Reach out to Belmont Instrument Corporation for guidance on next steps if your device shows a HALT 4 error.
Yes, one death has been reported potentially related to this issue.
Check if your CritiCool device has a serial number starting with '99' followed by 12 digits (e.g., 9978580900011). The full list of affected serial numbers is provided in the recall notice.
No, if the device displays a HALT 4 error that cannot be resolved through reboot, it must be stopped immediately.
We’ve drafted a message you can send Belmont Instrument to request your refund or repair — edit it as you like.
Subject: Recall Z-0153-2023 — Belmont Instrument Belmont Instrument Hello, I own a Belmont Instrument that is covered by recall Z-0153-2023 from Belmont Instrument. 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.
