FDA-Device2022-11-09Class II
CritiCool, thermoregulation device
Belmont Instrument Corporation
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
158 (US); 803 (OUS)
Manufactured in
780 Boston Rd, N/A, Billerica, MA, United States
Products
CritiCool, thermoregulation device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2023Don't want to check this manually?
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