GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions f
FDA device recall Z-0700-2013 · posted 2013-01-22 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
- Action taken
- AMS sent "NOTICE OF DEVICE FIELD CORRECTIVE ACTION" letters dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-408-456-3320 for questions about this notification.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 389 devices, all model numbers.
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-12-11
- Date posted
- 2013-01-22
- Date terminated
- 2014-02-13
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREENLIGHT XPS LASER SYSTEM (K092735) | American Medical Systems, Inc. | 2009-11-09 |
| GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719) | Laserscope | 2006-12-01 |