Recall Z-0556-06 ยท GEX Powered Laser Surgical Instrument
Lumenis Inc.
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
| Date | Feb 23, 2006 (initiated Feb 9, 2006) |
| Status | Terminated |
| Reason | During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip. |
| Root cause | Other |
| Action | On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip. |
| Quantity | 3,426 units |
| Distribution | The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003614 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM Coherent Star, Mar 13, 2001 |