Events

Recall of Device Recall DXD 600

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA Healthcare Corp..

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
    68752
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2014
  • Event Initiated Date
    2014-07-02
  • Event Date Posted
    2014-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128600
  • 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
    Some customers reported that while using the dx-d600 in room or exam preparation, the overhead tube crane (otc) showed increased velocity and uncontrolled longitudinal movement.
  • Action
    AGFA HealthCare sent an URGENT FIELD SAFETY NOTICE letter dated July 2, 2014 to affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgment form, via FAX-Back or email. A Mandatory Service Bulletin DIS012.14E/No. 32, was released June 30, 2014, to implement the mandatory upgrade of full automatic DX-D600 systems to version 3.6 to prevent unexpected system movements. This Mandatory Service Bulletin was issued to Agfa DR Specialists to perform the service. A 2nd release will be implemented to upgrade semi-automatic systems. For questions contact your local AGFA HealthCare organization 1-877-777-2432.

Device

Device Recall DXD 600
  • Model / Serial
    Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
  • Product Description
    DX-D 600 - DXD Imaging Package || Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Manufacturer Address
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    USFDA