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Lightsheer DESIRE laser (2015-03-13)
- Starting date:
- March 13, 2015
- Posting date:
- April 27, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53025
Recalled Products
A. Lightsheer DESIRE laser
Reason
A discrepancy in subject device product labeling exists. The programmed software settings were determined to be higher than those required for the model of hand piece deployed on patients. An examination of subject device light sheer desire laser system labeling found the physician recommended treatment settings did not match the settings identified by the subject device software when specific patient skin types and hair color were selected. An inexperienced device operator would not be aware the treatment settings identified by the system software are incorrect.
Affected products
A. Lightsheer DESIRE laser
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LIGHTSHEER DESIRE
Companies
- Manufacturer
-
Lumenis Inc.
3959 West 1820 South
Salt Lake City
84104
Utah
UNITED STATES