Events

Recall of FLEXIBLE PHOSPHOR SCREEN/GP/FOR USE WITH CR 500 SYSTEMS

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
    67074
  • Event Risk Class
    II
  • Event Initiated Date
    2005-04-29
  • 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
    Manufacturer has received complaints of near misdiagnoses caused by artifacts on images.

Device

FLEXIBLE PHOSPHOR SCREEN/GP/FOR USE WITH CR 500 SYSTEMS
  • Model / Serial
    Model Catalog: 160-5906 (Lot serial: 051CO.); Model Catalog: 812-7334 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 825-9269 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 167-8663 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 810-7823 (Lot serial: 051CO.); Model Catalog: 167-8663 (Lot serial: 051CO.); Model Catalog: 825-9269 (Lot serial: 051CO.); Model Catalog: 812-7334 (Lot serial: 051CO.); Model Catalog: 160-5906 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 810-7823 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 167-8663 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 825-9269 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 812-7334 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 160-5906 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 810-7823 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 167-8663 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 825-9269 (Lot serial: ALL LOT NUMBERS WITH X
  • Product Description
    KODAK FLEXIBLE PHOSPHOR SCREEN
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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