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
    21592
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-27
  • Event Country
  • 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
    During centricity to centricity exam transfer a potential image loss can occur while images are being transferred from the source to destination server. when another process in the destination server attempts to access the same object or table the transfer process of a particular image may be terminated. once terminated the transfer service skips the image being sent and continues to send the next image in the exam.

Device

  • Model / Serial
    Model Catalog: K2034W (Lot serial: >10 numbers contact mfg); Model Catalog: K2033LG (Lot serial: >10 numbers contact mfg); Model Catalog: K2033L (Lot serial: >10 numbers contact mfg); Model Catalog: CENTRICITY PACS 3.1.1.1 (Lot serial: >10 numbers contact mfg); Model Catalog: K2022PF (Lot serial: >10 numbers contact mfg); Model Catalog: K2022PE (Lot serial: >10 numbers contact mfg); Model Catalog: K2033JS (Lot serial: >10 numbers contact mfg)
  • Product Description
    CENTRICITY PACS SYSTEM
  • Manufacturer

Manufacturer