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
    69958
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-23
  • 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
    Potential video splitter failure inside ge equipment cabinet could occur with no warning & prevent x-ray image display. system cannot be recovered without service intervention.

Device

INNOVA 4100IQ - MAIN UNIT
  • Model / Serial
    Model Catalog: 2335129 (Lot serial: 406451BU5 398530BU6); Model Catalog: 2335129 (Lot serial: S/N'S 417372BU0 405584BU4); Model Catalog: S1872LC (Lot serial: 364939BU9); Model Catalog: S1872LC (Lot serial: 354853BU6 417895BU0); Model Catalog: S1872LC (Lot serial: S/N'S 397054BU8 349890BU4); Model Catalog: S1872LC (Lot serial: 347469BU9 419496BU5)
  • Product Description
    INNOVA 4100 IQ - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)