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Biolase Technology Inc recalls WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Recalled August 27, 2014 · FDA recall Z-2263-2014 · Biolase Technology
Hazard
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. · FDA Class II
Units
117 units
Sold at
Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE.
Description
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.
Product
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Manufacturer(s)
Biolase Technology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →