Recall Z-0842-06 ยท GXE Leukotome
Candela Laser Corporation
Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300
| Date | May 4, 2006 (initiated Jan 17, 2006) |
| Status | Terminated |
| Reason | Handle fires even when the finger is off the switch |
| Root cause | Other |
| Action | Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system. |
| Quantity | 59 units |
| Distribution | Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland |
| FDA record | Open on fda.gov |