Health product recall

ComboLab System

Last updated

Summary

Product
ComboLab System
Issue
Medical devices - Performance
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 System

SVS23350013SA
SVS23460017SA
SVS23480016SA
SVS23480012SA
SVS23290001SA
SVS23330007SA
SVS23360008SA

2300000-005

Issue

GE Healthcare has become aware that capacitors in certain Prucka 3 Amplifiers used with Cardiolab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms. 

Recall Start Date: May 1, 2024

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-75523

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