Events

Recall of LIGHTSPEED VCT CT SYSTEM - CONSOLE

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
    23872
  • Event Risk Class
    III
  • Event Initiated Date
    2009-12-18
  • 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 hd or lightspeed 7.2 systems the 80 kvp ctdi (ct dose index) adjustment factors & ctdi adjustment factors associated with 2x0.625 (1.25 mm) & 4x0.625 (2.5mm) aperture settings were incorrect.

Device

LIGHTSPEED VCT CT SYSTEM - CONSOLE
  • Model / Serial
    Model Catalog: 5212920-3XX (Lot serial: S/N 412477CN2 413732CN9); Model Catalog: 5232083-X (Lot serial: 409449CN6 409530CN3); Model Catalog: 5232083-X (Lot serial: S/N 409191CN4 409447CN0)
  • Product Description
    LIGHTSPEED VCT CT SYSTEM - CONSOLE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)