Company: Biolase Technology Inc
Date of Enforcement Report: 8/27/2014
Class lI:
PRODUCT
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. Recall Number Z-2263-2014
REASON
Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF.
RECALLING FIRM/MANUFACTURER
Biolase Technology Inc, Irvine, CA on 6/12/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide and Internationally
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