Events

Recall of CARESTREAM DRX-TRANSPORTABLE SYSTEM / FIELD PORTABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA COMPANY.

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
    53065
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Carestream recently received reports of a non-diagnostic image on exams when a normal exposure mode (nem) image is taken immediately prior to an extended exposure mode (eem) image with the system in fast preview mode. investigation revealed that the directview version 5.5 and 5.6 console software when used with drx-1 detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.

Device

CARESTREAM DRX-TRANSPORTABLE SYSTEM / FIELD PORTABLE
  • Model / Serial
    Model Catalog: 1021286 (Lot serial: 5007); Model Catalog: 1021286 (Lot serial: 107)
  • Product Description
    DRX TRANSPORTABLE SYSTEM
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC