American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for
FDA device recall Z-0131-2008 · posted 2008-02-26 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- Control knob break: The knob used to finely control the direction of the laser energy may break.
- Action taken
- American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 611 units
- Distribution
- Worldwide Distribution - USA and Singapore.
- Date initiated
- 2007-06-18
- Date posted
- 2008-02-26
- Date terminated
- 2010-03-23
- 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 |
|---|---|---|
| GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719) | Laserscope | 2006-12-01 |
| LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K010284) | Laserscope | 2001-05-01 |