Events

Recall of INNOVA 4100IQ - 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
    151363
  • Event Risk Class
    II
  • Event Initiated Date
    2008-06-02
  • 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
    Jnexpected system lockups may occur while using the image auto-archiving function. if it occurs during x-ray imaging the acquisition fails and the user has to reset the system.

Device

INNOVA 4100IQ - MAIN UNIT
  • Model / Serial
    Model Catalog: 2335129 (Lot serial: MANUFACTURER); Model Catalog: 2335139-2 (Lot serial: MANUFACTURER); Model Catalog: S18741AM (Lot serial: CONTACT); Model Catalog: 2335139-2 (Lot serial: CONTACT); Model Catalog: S18741AM (Lot serial: >10 NUMBERS); Model Catalog: 2335129 (Lot serial: >10 NUMBERS); Model Catalog: 2335139-2 (Lot serial: >10 NUMBERS); Model Catalog: S18741AM (Lot serial: MANUFACTURER); Model Catalog: 2335129 (Lot serial: CONTACT); Model Catalog: 2335139-4 (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: S18751AP (Lot serial: 498683BU2 7C20329 520071BU2); Model Catalog: 2335139-4 (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: 2335139-4 (Lot serial: 498683BU2 7C20329 520071BU2)
  • Product Description
    INNOVA 4100 IQ - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)