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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