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Candela Corporation recalls Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. an
Recalled November 27, 2013 · FDA recall Z-0348-2014 · Candela
Hazard
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. · FDA Class II
Units
1258 units
Sold at
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.
Description
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
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
Manufacturer(s)
Candela Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →