Events

Recall of Device Recall Carestream DRX Evolution System (Standard Q)

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
    67060
  • Event Risk Class
    Class 2
  • Event Number
    Z-0774-2014
  • Event Initiated Date
    2013-08-20
  • Event Date Posted
    2014-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124636
  • 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
    Carestream received a report of an exposure being initiated without a patient image captured. the patient was imaged 2 times before an image was captured. the field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
  • Action
    The Center for Devices and Radiological Health (CDRH) understands that the CAP (Corrective Action Plan) involving 4 units will consist of the following: a. Distribution of a letter to all affected customers informing them of the issue, how to prevent the issue including a reminder of instructions for proper x-ray system setup and operation found in the User Manual. The letter will also include actions to be taken by Carestream to correct the issue. This communication will be marked and distributed pursuant to the requirements of 21 CFR 1003.21. b. The next stage of correction will be the installation of a software patch to any potentially affected customer sites. The software patch has been developed to prevent the system from allowing an exposure when the bucky and detector are not selected. This patch has been verified and proven successful prior to rollout in manufacturing. Once receiving FDA approval on the corrective action plan, the correction will be implemented within the US to all affected devices at identified customer sites. c. The completion of the Corrective Action Plan, once approved, is expected to take approximately 3 months. d. Carestream will provide FDA with a report demonstrating effective closure of the activity. CDRH approves the draft of the customer notification letter and CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call 585-627-6473.

Device

Device Recall Carestream DRX Evolution System (Standard Q)
  • Model / Serial
    Serial Numbers 5049, 5073, 5133, 5162
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TX, IL, and GA.
  • Product Description
    Carestream DRX Evolution System (Standard Q) || The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
  • 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