BEUDAMED
    FDA Recall Terminated

    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures

    Recall: Z-2651-2017 · Initiated May 25, 2017

    Recall

    Recall Number
    Z-2651-2017
    Event Number
    77250
    Firm
    Carestream Health Inc
    FEI Number
    1315356
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 25, 2017
    Posted
    June 19, 2017
    Terminated
    June 13, 2018
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures

    Reason

    Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.

    Action

    Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.

    Quantity

    Domestic: 1449 units; Foreign: 1416 units