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Terminated

Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color

FDA Recall Z-0291-04 · Posted 2004-01-01

Recalling FirmCandela Laser Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2003-11-25
Date Terminated2006-12-06
Product Quantity506 units

Reason for Recall

Laser may pulse and not dispense cryogen resulting in patient injury

Firm Action

Candela notified direct customers and distributors by letter dated 11125/03 and issued Certified Mail. Accounts are requested to perform two tests on the unit to determine if the unit has the problem. If a unit fails, Candela's Field Service will make the repair. Distributors are requested to notify their customers.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030834CANDELA SMOOTHBEAM LASER SYSTEMCandela Corp. · 2003-12-03K030846CANDELA SMOOTHBEAM LASER SYSTEMCandela Corp. · 2003-09-16K022884CANDELA SMOOTHBEAM LASER SYSTEMCandela Corp. · 2003-01-22K013825CANDELA SMOOTHBEAM LASER SYSTEMCandela Corp. · 2002-02-15

Official Source

View FDA Recall →

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

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