Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Numb
FDA device recall Z-0842-06 · posted 2006-05-04 · Terminated
Recall details
- Recalling firm
- Candela Laser Corporation
- Reason for recall
- Handle fires even when the finger is off the switch
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GXE
- Quantity affected
- 59 units
- Distribution
- Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland
- Date initiated
- 2006-01-17
- Date posted
- 2006-05-04
- Date terminated
- 2006-05-04
- Location
- Wayland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY (K051359) | Candela Corp. | 2005-07-13 |
| CANDELA FAMILY OF PULSE DYE LASER SYSTEMS (K050673) | Candela Corp. | 2005-06-13 |