Device product
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
Z-0348-2014
Product summary
- Event
- Event 66773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1258 units
- Official record key
device-enforcement:Z-0348-2014
Official wording
Reason: Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Code information: GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214
Distribution pattern: 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 Kingdom.
Derived failure modes
-
Unknown
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.