Biosense Webster Recalls CARTO 3 EP Navigation Systems in China
Biosense Webster is voluntarily re-installing 338 CARTO 3 EP Navigation Systems in China, Hong Kong, and Brazil that were moved without required testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary correction for a procedural deviation (lack of testing after relocation) with no reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Biosense Webster, Inc. is initiating a voluntary correction to re-install 338 CARTO 3 EP Navigation Systems and Accessories. The affected units, identified by product codes FG540000 and FG540000C and software versions v 3.2, v 4.3, and v 2.3, were moved and installed in China without testing and approval by Biosense Webster Technical Services, contrary to the Instructions for Use (IFU).
The CARTO 3 EP Navigation System is intended for use in catheter-based cardiac electrophysiological (EP) procedures, providing information about the electrical activity of the heart and catheter location. The recall involves units distributed internationally to China, Hong Kong, and Brazil.
This action is a voluntary correction to ensure the devices are properly tested and approved following relocation. No specific instructions for end-users are provided in the source text, as the correction involves re-installation by the manufacturer's technical services.
The recalled product
- Product
- CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides i
- Manufacturer
- Biosense Webster, Inc.
- Hazard
- Affected units
- 338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- V 3.2: 2258
- 10284
- 10332
- 10345
- 11640
- 11642
- 60011
- 60012
- 60606
- 60611
- 60613
- 60618
- 60621
- 60625
- 60634
- 60644
- 60651
- 60654
- 60657
- 60658
Distribution
Distribution scope not specified by the agency.
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