Events

Recall of KODAK DIRECTVIEW CR 950 SYSTEM - MAIN UNIT

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
    30709
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-25
  • 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
    The directview cr version 5.4 software used with the 24 x 30 cm type gp/pq or hr cassettes creates an image size which is 16 % smaller than true size. as a result images smaller than true size will be printed or displayed to the cr user interface or pacs workstation. this will only occur when the true size option is selected within the image editing menu. other uses are not impacted.

Device

KODAK DIRECTVIEW CR 950 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 132-7238 (Lot serial: 3030); Model Catalog: 132-7238 (Lot serial: 3031); Model Catalog: 132-7238 (Lot serial: 3033); Model Catalog: 854-7275 (Lot serial: 3147); Model Catalog: 854-7275 (Lot serial: 3148); Model Catalog: 854-7275 (Lot serial: 3144); Model Catalog: 854-7275 (Lot serial: 3150); Model Catalog: 854-7275 (Lot serial: 3104); Model Catalog: 854-7275 (Lot serial: 3152); Model Catalog: 854-7275 (Lot serial: 3013); Model Catalog: 854-7275 (Lot serial: 3146); Model Catalog: 854-7275 (Lot serial: 3137)
  • Product Description
    KODAK DIRECTVIEW CR 950 SYSTEM
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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