Health product recall

Combolab AltiX

Last updated

Summary

Product
Combolab AltiX
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Combolab AltiX SVS23040008SA SVS23040003SA 2300000-005

Issue

GE Healthcare has become aware that a diode on the power supply of the Prucka 3 Amplifier used with cardiolab/combolab systems could reach elevated temperatures. This could cause the amplifier to fail and consequently power off and become inoperable.

Recall Start Date: August 8, 2023

 

Additional information

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

GE Medical Systems Information Technologies Inc.

9900 Innovation Drive, Wauwatosa, Wisconsin, United States, 53226

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74139