Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-
FDA device recall Z-0028-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Lumenis Inc.
- Reason for recall
- Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
- Action taken
- On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 10,815
- Distribution
- Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
- Date initiated
- 2006-08-29
- Date posted
- 2006-10-12
- Date terminated
- 2007-01-22
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703) | Lumenis | 2001-08-29 |