AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System i
FDA device recall Z-1397-2019 · posted 2019-05-22 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
- Action taken
- Boston Scientific issued to the user level the correction/removal via a customer notification letter via FedEx or hand delivery by a Boston Scientific agent on 4/9/19. Letter provides recommendations to the user until a field repair can be completed or a replacement console can be provided. A Boston Scientific representative will be in contact with you directly to schedule a field repair or replacement at your facility. The console can continue to be used during this time following the recommendations within the letter.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 18 (OUS)
- Distribution
- Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Afri
- Date initiated
- 2019-04-08
- Date posted
- 2019-05-22
- Date terminated
- 2023-05-10
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AURIGA XL (K111475) | Starmedtec GmbH | 2011-09-28 |