FDA-Device2014-08-27Class II
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Biolase Technology Inc
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.
Sold states
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.
Affected count
117 units
Manufactured in
4 Cromwell, Irvine, CA, United States
Products
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2263-2014Don't want to check this manually?
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