Events

Recall of Device Recall DRXRevolution Mobile XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77250
  • Event Risk Class
    Class 2
  • Event Number
    Z-2651-2017
  • Event Initiated Date
    2017-05-25
  • Event Date Posted
    2017-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155553
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, mobile - Product Code IZL
  • 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.

Device

Device Recall DRXRevolution Mobile XRay System
  • Model / Serial
    Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Manufacturer Address
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA