BEUDAMED
    FDA Enforcement Class II 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 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2651-2017
    Event ID
    77250
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    May 25, 2017
    Classification Date
    June 29, 2017
    Termination Date
    June 13, 2018
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    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.

    Code Info

    Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482

    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