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Elite XPL (Pulsed Light) Handpiece (2014-10-08)

Starting date:
October 8, 2014
Posting date:
October 22, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41805

Recalled Products

Elite XPL (Pulsed Light) Handpiece

Reason

Cynosure has identified a potential situation where the user of the device could receive an electrical shock under certain conditions. If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light hand piece, there is a potential risk of an electrical shock.

Affected products

Elite XPL (Pulsed Light) Handpiece

Lot or serial number

All serial numbers.

Model or catalog number

100-7009-700

Companies
Manufacturer
Cynosure Inc.
5 Carlisle Road
Westford
90426
Massachusetts
UNITED STATES