Events

Recall of DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR

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
    19852
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-03
  • 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 has identified a software defect that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (i.E. radio opaque ruler) when building a composite image and the technologist relies solely on the auto stitching software there could be a risk of undetected stitching error that would otherwise get noticied and corrected with the use of manual stitching.

Device

DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
  • Model / Serial
    Model Catalog: 1010982 (Lot serial: 5573); Model Catalog: 1731678 (Lot serial: 4569); Model Catalog: 1010982 (Lot serial: 5393); Model Catalog: 1010982 (Lot serial: 5266); Model Catalog: 8001174 (Lot serial: 5408); Model Catalog: 1731678 (Lot serial: 5408); Model Catalog: 8001174 (Lot serial: 4076); Model Catalog: 1731678 (Lot serial: 4076); Model Catalog: 8001174 (Lot serial: 5442); Model Catalog: 1731678 (Lot serial: 5442); Model Catalog: 8001174 (Lot serial: 4879); Model Catalog: 1731678 (Lot serial: 4879); Model Catalog: 8001174 (Lot serial: 4767); Model Catalog: 1731678 (Lot serial: 4767); Model Catalog: 8001174 (Lot serial: 4670); Model Catalog: 1731678 (Lot serial: 4670); Model Catalog: 8001174 (Lot serial: 4588); Model Catalog: 1731678 (Lot serial: 4588); Model Catalog: 8001174 (Lot serial: 4570); Model Catalog: 1731678 (Lot serial: 4570); Model Catalog: 8001174 (Lot serial: 4569); Model Catalog: 1010982 (Lot serial: 5572)
  • Product Description
    DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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