BEUDAMED
    FDA Recall 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 · Initiated June 12, 2012

    Recall

    Recall Number
    Z-2202-2012
    Event Number
    62310
    Firm
    Carestream Health, Inc.
    FEI Number
    1317307
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 12, 2012
    Posted
    August 13, 2012
    Terminated
    May 25, 2016
    Address
    1049 Ridge Rd, W Rochester, NY, 14615-2731

    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.

    Action

    Firm sent consignees "Urgent: Customer Notification and Field Corrective Action" letters on June 8, 2012. The letters described the issue and provided recommended actions. Service dealers will contact all affected consignees to evaluate the battery. U.S. customers with questions can contact Carestream Customer Care at 800-328-2910. Customers outside the United States should contact their local Carestream service number.

    Distribution

    Worldwide Distribution, including Nationwide (USA).

    Quantity

    9971 units