Health product recall

Criticool Control Unit

Last updated

Summary

Product
Criticool Control Unit
Issue
Medical devices - Performance issue
What to do

Contact manufacturer for additional information. 

Audience
Healthcare

Affected products

Affected Products Lot or serial number Model or catalogue number
Criticool Control Unit 99110992900015 99110992900018 99110698100045 200-00236

Issue

The pump that circulates the water from the Criticool® device into the Curewrap® may experience premature failure due to loose hardware on the pump component. This premature failure leads to the Criticool® device displaying a halt 4 error, from which the device cannot recover even after a device reboot.

Recall start date: November 15, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Belmont Medical Technologies

780 Boston Road, Billerica, Massachusetts, United States, 01821

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72330

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