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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