Events

Recall of Device Recall KODAK DirectView DR 9000 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
    68406
  • Event Risk Class
    Class 2
  • Event Number
    Z-2137-2014
  • Event Initiated Date
    2014-05-30
  • Event Date Posted
    2014-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127530
  • 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, stationary - Product Code KPR
  • Reason
    A control system failure may cause the u-arm to move downward unexpectedly when the radiology technologist is positioning the equipment using the "up" or "down" control buttons. downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the emergency stop button is activated or the equipment bump sensor contacts an object.
  • Action
    Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number.

Device

Device Recall KODAK DirectView DR 9000 System
  • Model / Serial
    Service Code 1534
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
  • Product Description
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
  • 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