Events

Recall of DISCOVERY RX PET/CT SCANNER SYSTEM - MAIN UNIT

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
    103960
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-15
  • 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
    Certain computed tomography dose index (ctdi) adjustment factors used for manual calculation from technical reference manual (trm) are incorrect which may lead to inaccurate ctdi manual calculation.

Device

DISCOVERY RX PET/CT SCANNER SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: S9116LR (Lot serial: 00000413213CN0); Model Catalog: S9116LA (Lot serial: 00000369417CN1 00000385376CN9); Model Catalog: S9116LA (Lot serial: 00000391656CN6 00000393942CN8); Model Catalog: S9116LA (Lot serial: 00000411721CN4); Model Catalog: S9116LR (Lot serial: S/N'S 00000406672CN6); Model Catalog: A90962AC (Lot serial: S/N 00000005070YC8); Model Catalog: S9116LE/ME (Lot serial: S/N'S 00000388336CN0); Model Catalog: B7868JA/JD (Lot serial: >10 NUMBERS); Model Catalog: B7868JA/JD (Lot serial: MANUFACTURER); Model Catalog: S9116LE/ME (Lot serial: 00000404536CN5 00000406414CN3); Model Catalog: B7868JA/JD (Lot serial: CONTACT)
  • Product Description
    DISCOVERY RX PET/CT SCANNER SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)