Events

Recall of Device Recall DRXRevolution

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
    65469
  • Event Risk Class
    Class 2
  • Event Number
    Z-0126-2014
  • Event Initiated Date
    2013-06-06
  • Event Date Posted
    2013-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119011
  • 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 health inc. is recalling the power plug on their drx-revolution mobile x-ray system due to the item generating sparks and becoming warm to touch.
  • Action
    On June 6, 2013 Carestream Health Inc. initiated a recall for the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health Inc. will replace the power plug in all potentially impacted DRX-Revolution Mobile X-Ray Systems. Your Carestream service representative will contact you to answer any questions and schedule a visit to replace the plug of your Mobile X-Ray System as soon as possible. If you have any questions or concerns, or if you experience any issue with your plug prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.

Device

Device Recall DRXRevolution
  • Model / Serial
    Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.
  • Product Description
    Carestream DRX-Revolution Mobile X-ray System. || Produces radiographic images.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

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