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Terminated

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

FDA Recall Z-0348-2014 · Posted 2013-11-18

Recalling FirmCandela Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2013-11-06
Date Terminated2015-06-08
Product Quantity1258 units

Reason for Recall

Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

Firm 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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024260CANDELA GENTLELASE FAMILY OF LASER SYSTEMSCandela Corp. · 2003-03-21K024335CANDELA GENTLELASE FAMILY OF LASER SYSTEMSCandela Corp. · 2003-03-12K972767CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASERCandela Corp. · 1997-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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