Recall Z-0153-2023— Belmont Instrument Corporation

Name: FDA recall Z-0153-2023
Creator: U.S. Food and Drug Administration
Published: 2021-07-20

Class II · Ongoing

Class II FDA medical device recall by Belmont Instrument Corporation, initiated 2021-07-20. It names one FDA 510(k) clearance: K083662. Product: CritiCool, thermoregulation device. Reason: 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..

Recalling firm: Belmont Instrument Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-07-20
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K083662 — CRITICOOLMtre Advanced Technology , Ltd.·cleared 2009-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CritiCool, thermoregulation device

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.