Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and
FDA device recall Z-0348-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Candela Corporation
- Reason for recall
- Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
- Action taken
- Candela notiifed Distributors on 11/8/13 through e-mail, Certified return receipt request, or FedEx package containing distributor letter, customer letter for translation and customer lists. A software update to Version 2.0 will be issued to the user by a field service representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 1258 units
- Distribution
- Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates a
- Date initiated
- 2013-11-06
- Date posted
- 2013-11-18
- Date terminated
- 2015-06-08
- 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 GENTLELASE FAMILY OF LASER SYSTEMS (K024260) | Candela Corp. | 2003-03-21 |
| CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K024335) | Candela Corp. | 2003-03-12 |
| CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER (K972767) | Candela Corp. | 1997-12-04 |