Recall Z-0898-2018 ยท GEX Powered Laser Surgical Instrument
Boston Scientific Corporation
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
| Date | Mar 5, 2018 (initiated Sep 22, 2017) |
| Status | Terminated |
| Reason | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. |
| Root cause | Process design |
| Action | Urgent Medical Device Field Correction letters, dated September 2017, were sent to distributors and medical facilities with instructions for acknowledging the notice and making corrections. The letter identified the affected device and the reason for the correction. Customers were to check their inventory, segregate, and cease distribution for the affected devices. Customers were to complete and return the acknowledgment form. **NO PRODUCT IS BEING RECALLED AND YOU ARE NOT REQUIRED TO RETURN PRODUCT TO BOSTON SCIENTIFIC** |
| Quantity | 9 |
| Distribution | International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111475 | AURIGA XL Starmedtec GmbH, Sep 28, 2011 |