BEUDAMED
    FDA Recall Terminated

    Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK COMPANY (now known as Carestream Heath Inc.) Rochester, NY 14608, or CARESTREAM HEALTH, INC., Rochester, NY 14608.

    Recall: Z-0731-2008 · Initiated December 21, 2007

    Recall

    Recall Number
    Z-0731-2008
    Event Number
    46266
    Firm
    Carestream Health, Inc.
    FEI Number
    1315356
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 21, 2007
    Posted
    February 23, 2008
    Terminated
    April 10, 2008
    Address
    150 Verona Street, Rochester, NY, 14608-1733

    Description

    Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK COMPANY (now known as Carestream Heath Inc.) Rochester, NY 14608, or CARESTREAM HEALTH, INC., Rochester, NY 14608.

    Reason

    Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.

    Action

    On 12/21/07, Service Bulletins (dated December 2007) were sent to consignees informing them of design modification, and providing modification instructions. The firm followed up with telephone calls to the direct user sites to schedule appointments to visit each site, in order to make the necessary modifications. The firm will be installing Safety Adaptation Board and software into all the affected DR3000 systems.

    Distribution

    Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA.

    Quantity

    Domestic - 19 units