CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 an
FDA device recall Z-2776-2016 · posted 2016-09-09 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- 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).
- Action taken
- Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved by the Biosense Webster, Inc.Technical Services Team. The letter informs the customers of the actions to be taken. Actions Requested on Your Part: 1. Read this Medical Device Correction notification carefully. 2. If a CARTO 3 System currently resides within your hospital, the system has been corrected, and you should ensure that you have received a Field Service Report that indicates the system is in order. For questions regarding this recall call 909-839-8500. 3. Review, complete, sign, and return the Acknowledgement Form in accordance with the instructions listed on the form. 4. In the future, if a CARTO 3 System is installed in your facility, you should only conduct a clinical procedure after you have received a Field Safety Report dated after the installation of the device indicating that the system is in order. 5. Maintain awareness of this notice and pass this notice on to anyone in your facility that needs to be informed. Customers with any questions are instructed to contact their Biosense Webster, Inc. sales representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 338 units
- Distribution
- International Distribution to China, Hong Kong and Brazil.
- Date initiated
- 2016-08-15
- Date posted
- 2016-09-09
- Date terminated
- 2017-01-20
- Location
- Irwindale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 (K133916) | Biosense Webster, Inc. | 2014-07-01 |
| CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 (K132782) | Biosense Webster, Inc. | 2014-01-24 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 (K112007) | Biosense Webster, Inc. | 2011-10-05 |