GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units)
FDA device recall Z-0130-2008 · posted 2008-03-20 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- Component missing: Some products were issued without thermal protection switches.
- Action taken
- AMS issued Important: Medical Device Correction letters, dated April 17, 2007, to its US and international consignees by mail, instructing them to return an acknowledgement form. The letter informs customers that some HPS systems may lack a motor overload switch, that the firm believes that there is no immediate safety issue, and installation of the MOL switch will be conducted during normal preventive maintenance. AMS expects to complete installation of the switches by end of August 2007.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 169 units
- Distribution
- Worldwide Distribution - USA, Italy, France, Germany, Spain, UK, Denmark, Sweden, Australia, India, Japan, Greece, Switzerland, Saudi Arabia, Thailand, Turkey, Singapore, Taiwan/Hong Kong (China), and
- Date initiated
- 2007-04-17
- Date posted
- 2008-03-20
- 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 |