BEUDAMED
    FDA Recall Terminated

    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

    Recall: Z-2263-2014 · Initiated June 12, 2014

    Recall

    Recall Number
    Z-2263-2014
    Event Number
    68870
    Firm
    Biolase Technology Inc
    FEI Number
    2027755
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 12, 2014
    Posted
    August 18, 2014
    Terminated
    October 6, 2014
    Address
    4 Cromwell, Irvine, CA, 92618-1816

    Description

    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

    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.

    Action

    An Urgent Medical Device Correction letter dated 6/12/2014 was sent to all customers who purchased the WaterLase iPlus Dental Laser System. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that a Field Service Engineer can install the software update. Customers with are instructed to contact Customer Service at (800) 321-6717.

    Distribution

    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.

    Quantity

    117 units