Z-0348-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2013
- Initiation Date
- November 6, 2013
- Termination Date
- June 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1258 units
Product Description
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
Reason for Recall
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
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.
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