GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potenti
FDA device recall Z-2502-2010 · posted 2010-09-25 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- Product may be packed with incorrect external or internal labels and/or missing product insert.
- Action taken
- Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 11668 units
- Distribution
- Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
- Date initiated
- 2010-01-22
- Date posted
- 2010-09-25
- Date terminated
- 2011-01-25
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719) | Laserscope | 2006-12-01 |