Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
FDA device recall Z-0898-2018 · posted 2018-03-05 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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**
- Root cause
- Process design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 9
- Distribution
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Date initiated
- 2017-09-22
- Date posted
- 2018-03-05
- Date terminated
- 2018-08-14
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AURIGA XL (K111475) | Starmedtec GmbH | 2011-09-28 |