Events

Recall of SECURVIEW DX DIAGNOSTIC WORKSTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHRISTIE INNOMED INC..

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
    82892
  • Event Risk Class
    II
  • Event Initiated Date
    2012-03-01
  • 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
    Two problems related to hologic released sofware 7.3.0 were reported: (1). measurements made on tomosynthesis images in a quadruple tiling mode will not have the correct value when displayed in other modes. and (2). annotations (gsps) made on tomosynthesis images may have incorrect placement on images if the annotations were made on images that were flipped from their original orientation.

Device

SECURVIEW DX DIAGNOSTIC WORKSTATION
  • Model / Serial
    Model Catalog: SVDX-00400 (Lot serial: 3980109B0672); Model Catalog: SVDX-00600 (Lot serial: 2981208B2456); Model Catalog: SVDX-00300 (Lot serial: 2981208B2456); Model Catalog: SVDX-00400 (Lot serial: 2981208B2456); Model Catalog: SVDX-00600 (Lot serial: 2980908B2284); Model Catalog: SVDX-00300 (Lot serial: 2980908B2284); Model Catalog: SVDX-00400 (Lot serial: 2980908B2284); Model Catalog: SVDX-00600 (Lot serial: 2981208B2443); Model Catalog: SVDX-00300 (Lot serial: 2981208B2443); Model Catalog: SVDX-00400 (Lot serial: 2981208B2443); Model Catalog: SVDX-00600 (Lot serial: 3961208B0414); Model Catalog: SVDX-00300 (Lot serial: 3961208B0414); Model Catalog: SVDX-00400 (Lot serial: 3961208B0414); Model Catalog: SVDX-00600 (Lot serial: 2961208B0413); Model Catalog: SVDX-00300 (Lot serial: 2961208B0413); Model Catalog: SVDX-00400 (Lot serial: 2961208B0413); Model Catalog: SVDX-00600 (Lot serial: 3980109B0672); Model Catalog: SVDX-00300 (Lot serial: 3980109B0672)
  • Product Description
    SecurView DX and RT
  • Manufacturer
    CHRISTIE INNOMED INC.

Manufacturer

CHRISTIE INNOMED INC.