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
    76134
  • Event Risk Class
    Class 2
  • Event Number
    Z-1138-2017
  • Event Initiated Date
    2017-01-12
  • 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=152283
  • 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
    The firm received a complaint alleging that a drx revolution system could not be stopped when applying the brake. the revolution crashed into an elevator.
  • Action
    Carestream Health Inc. sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated December 29, 2016, and response forms were sent to the US customers via Certified Mail-Return Receipt Requested on January 12, and January 13, 2017, informing them of the problem. Customers are instructed to read and complete all information and return the response form within 5 working days to the following e-mail address: postmarketra@carestream.com, or fax the completed form to (585) 454-4493. UMDC Letters and Response Forms to Canadian Customers were sent the week of January 9, 2017, via courier. Field Safety Notice (FSN) Letters for the rest of world are in process. FSN Letters for the EMEA should be sent via courier starting later this week. US Carestream Customer Care Center #: 1-800-328-2910 (24/7). Outside of the US, please call your local Service support number.

Device

Device Recall DRXRevolution Mobile XRay System
  • Model / Serial
    Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
  • 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