Z-2776-2016 Class II Terminated
FDA device recall Z-2776-2016 was initiated by Biosense Webster, Inc. on August 15, 2016 and is designated Class II. Reason for recall: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical S… The recall status is terminated (terminated January 20, 2017). Affected quantity: 338 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- August 15, 2016
- Termination Date
- January 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338 units
Product Description
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 information about the electrical activity of the heart and catheter location during the procedure.
Reason for Recall
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
Distribution Pattern
International Distribution to China, Hong Kong and Brazil.
Code Information
V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528 V 4.3: 61053, 61054, 61059, 11701, 12664 V 2.3: 14218, 13208, 50203, 50531, 14718, 50573