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Terminated

Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display

FDA Recall Z-0509-2007 · Posted 2007-02-15

Recalling FirmCandela Laser Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2007-01-15
Date Terminated2014-02-03
Product Quantity474 laser systems total (all models)

Reason for Recall

Internal component may overheat causing the possibility of risk of fire or smoke

Firm Action

Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

Official Source

View FDA Recall →

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

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