Events

Recall of LIGHTSPEED 16 CT SCANNER SYSTEM

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
    46563
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-26
  • 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
    Gehc has updated the service manuals used to maintain these scanners to fix an incorrect torque value which is the source of the field action. fmi 25463 identified a torque issue with 5 volt supplies in ct and pet lightspeed systems and corrected the issue by field action as well as a technical manual update. this recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.

Device

LIGHTSPEED 16 CT SCANNER SYSTEM
  • Model / Serial
    Model Catalog: B7868JA (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S9118JS (Lot serial: 00000348810CN3); Model Catalog: S9118JS (Lot serial: 00000349405CN1)
  • Product Description
    LIGHTSPEED 16 CT SCANNER SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)