BEUDAMED
    FDA Recall Terminated

    Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

    Recall: Z-0516-2013 · Initiated April 27, 2012

    Recall

    Recall Number
    Z-0516-2013
    Event Number
    61870
    Firm
    Motorola Inc
    FEI Number
    3014423912
    Product Code
    RFZ
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 27, 2012
    Posted
    January 30, 2013
    Terminated
    June 29, 2018
    Address
    1 Motorola Plz, Holtsville, NY, 11742-1300

    Description

    Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

    Reason

    It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.

    Action

    Motorola Solutions, Inc. agrees to provide instructions for downloading and installing a software update from the internet, which will reduce the laser power to IEC Class 1 AELs. Purchasers will be provided an internet site and instructions for notifying Motorola Solutions, Inc. that the software installation and power reduction were successful, thereby completing the corrective action. corrections to all units is anticipated to be completed by May 2013. I. Notifications to all dealers and purchasers must be made, and the FDA NY District Office Recall Coordinator is to be included in the notifications. 2.Correction of all units to be completed by May 2013. 3.All products will be brought into compliance with the laser performance standard at no cost to the purchaser. For questions regarding this recall call 631-738-3474.

    Distribution

    Nationwide distribution

    Quantity

    16,961 units domestically