Events

Recall of CENTRICITY PACS WORKSTATION - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    95009
  • Event Risk Class
    II
  • Event Initiated Date
    2008-12-22
  • 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
    When using f12 key to mark patient study as completed a different report for a different study is being assigned to that study. when f12 pressed before report palette updated with selected study info.

Device

CENTRICITY PACS WORKSTATION - SOFTWARE
  • Model / Serial
    Model Catalog: K2004SR (Lot serial: S/N'S 2855II9 J16LX11); Model Catalog: K2022JA (Lot serial: 8WZFY11 F37C921 78550II1); Model Catalog: K2004SR (Lot serial: 8WZFY11 F37C921 78550II1); Model Catalog: K2022JA (Lot serial: GRZBX11 GY5KY11 BPWCY11); Model Catalog: K2004SR (Lot serial: GRZBX11 GY5KY11 BPWCY11); Model Catalog: K2022JA (Lot serial: BZL8Z01 BZOT211 B7NWZ11); Model Catalog: K2004SR (Lot serial: BZL8Z01 BZOT211 B7NWZ11); Model Catalog: K2022JA (Lot serial: S/N'S 2855II9 J16LX11)
  • Product Description
    CENTRICITY PACS WORKSTATION - SOFTWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)