AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, Sa
FDA device recall Z-1229-2011 · posted 2011-02-14 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
- Action taken
- AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to CustomerCare@ammd.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- ~242,000 units
- Distribution
- Worldwide Distribution including US
- Date initiated
- 2010-02-08
- Date posted
- 2011-02-14
- Date terminated
- 2011-02-14
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K010284) | Laserscope | 2001-05-01 |