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Belmont Instrument Corporation recalls CritiCool, thermoregulation device
Recalled November 9, 2022 · FDA recall Z-0153-2023 · Belmont Instrument
Hazard
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. · FDA Class II
Units
158 (US); 803 (OUS)
Sold at
Domestic distribution nationwide. Foreign distribution worldwide.
Description
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.
Product
CritiCool, thermoregulation device
Manufacturer(s)
Belmont Instrument Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →