GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by Americ
FDA device recall Z-0834-2011 · posted 2010-12-29 · Terminated
Recall details
- Recalling firm
- AMS Innovative Center - San Jose
- Reason for recall
- Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
- Action taken
- American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel. For questions regarding this recall call 847-855-6270.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 77 units
- Distribution
- Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
- Date initiated
- 2010-07-14
- Date posted
- 2010-12-29
- Date terminated
- 2011-01-03
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIBER ONE (K100746) | American Medical Systems | 2010-06-11 |