Recall Z-0348-2014 ยท GEX Powered Laser Surgical Instrument
Candela Corporation
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
| Date | Nov 18, 2013 (initiated Nov 6, 2013) |
| Status | Terminated |
| Reason | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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 and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United King |
| FDA record | Open on fda.gov |