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Waterlase iPlus Dental Laser System (2015-12-16)
- Starting date:
- December 16, 2015
- Posting date:
- January 22, 2016
- 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-56738
Affected Products
Waterlase iPlus Dental Laser System
Reason
The parameters settings in the Class 1 Cavity ComfortPrep preset screen were improperly set to 0.1 watt (low power setting) during programming at the factory (instead of the clinical setting of 5 watts)
Affected products
Waterlase iPlus Dental Laser System
Lot or serial number
72151144
Model or catalog number
7200854
Companies
- Manufacturer
-
Biolase, Inc.
4 Cromwell
Irvine
92618
California
UNITED STATES