BEUDAMED
    FDA Enforcement Class II Terminated

    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.

    Recall: Z-2202-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2202-2012
    Event ID
    62310
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    June 12, 2012
    Classification Date
    August 13, 2012
    Termination Date
    May 25, 2016
    Address
    1049 Ridge Rd W, Rochester, NY, 14615-2731, United States

    Description

    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.

    Reason

    Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

    Code Info

    All DRX-1 batteries manufactured before June 2012.

    Distribution

    Worldwide Distribution, including Nationwide (USA).

    Quantity

    9971 units