Recall Z-0051-2015 ยท GEX Powered Laser Surgical Instrument
Boston Scientific Corporation
StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457
| Date | Oct 8, 2014 (initiated Sep 30, 2014) |
| Status | Terminated |
| Reason | Product is not cleared for use with lasers other than the Auriga XL system |
| Root cause | No Marketing Application |
| Action | Boston Scientific sent an " Urgent Medical Device Recall Removal Immediate Action Required" letter dated September 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the account to check their inventory, remove any affected product from their inventory, and contact Boston Scientific for further instructions on returns. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their |
| Quantity | 33 units |
| Distribution | US Distribution including the states of NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111475 | AURIGA XL Starmedtec GmbH, Sep 28, 2011 |