Recall Z-0028-2007 ยท GEX Powered Laser Surgical Instrument
Lumenis Inc.
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
| Date | Oct 12, 2006 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product. |
| Quantity | 10,815 |
| Distribution | Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES Lumenis, Aug 29, 2001 |