BEUDAMED
    FDA Recall Terminated

    SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.

    Recall: Z-0587-2010 · Initiated August 8, 2008

    Recall

    Recall Number
    Z-0587-2010
    Event Number
    54153
    Firm
    Zap Lasers LLC
    FEI Number
    3005212363
    Product Code
    NVK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 8, 2008
    Posted
    January 21, 2010
    Terminated
    May 25, 2010
    Address
    2621 Pleasant Hill Rd, Ste B, Pleasant Hill, CA, 94523-2161

    Description

    SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.

    Reason

    The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.

    Action

    Zap Lasers sent a letter to affectedcustomers stating that their SoftLase diode laser is eligible for a compliance maintenance upgrade. The upgrades will be free of charge and will enhance the safety of the laser. Customers are encouraged to call the firm's customer service line at 888-876-4547 to schedule their RMA number and shipping instructions. The letter also lists the upgrades that are needed.

    Distribution

    Worldwide Distribution to 1397 consignees

    Quantity

    1375 units