Events

Recall of CENTRICITY PACS WORKSTATION - HARDWARE

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
    22491
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-07
  • 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
    1)a forced log off may occur during an open session 2)centricity enterprise web does not utilize calibration performed on image measurements in centricity ra1000 workstation.

Device

CENTRICITY PACS WORKSTATION - HARDWARE
  • Model / Serial
    Model Catalog: P0001L (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2080PN (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2033KK (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: P0001L (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: K2033KK (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2033KK (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001L (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001KA (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KA (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: 416360CVPACS); Model Catalog: P0001KC (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KC (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: K2034JP (Lot serial: >10 NUMBERS); Model Catalog: K2034JP (Lot serial: CONTACT); Model Catalo
  • Product Description
    CENTRICITY PACS WORKSTATION - HARDWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)