CritiCool, thermoregulation device
Reported: November 9, 2022 Initiated: July 20, 2021 #Z-0153-2023
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.
Details
- Recalling Firm
- Belmont Instrument Corporation
- Units Affected
- 158 (US); 803 (OUS)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
CritiCool, thermoregulation device. Recalled by Belmont Instrument Corporation. Units affected: 158 (US); 803 (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0153-2023.
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