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
    32528
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-20
  • 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
    A potential power supply failure inside the ge equipment cabinet could occur with no warning & prevent x-ray generation & image processing. if this occurs the system cannot be restarted.

Device

INNOVA 4100IQ - MAIN UNIT
  • Model / Serial
    Model Catalog: 2335129 (Lot serial: 432687BU2 406451BU5); Model Catalog: 2335129 (Lot serial: S/N'S 417372BU0 405584BU4); Model Catalog: 2335129 (Lot serial: 429328BU8 437542BU4); Model Catalog: 2335129 (Lot serial: 398530BU6); Model Catalog: S1872LC (Lot serial: S/N'S 409881BU0 397054BU8); Model Catalog: S1872LC (Lot serial: 419496BU5 427075BU7); Model Catalog: S1872LC (Lot serial: 417895BU0)
  • Product Description
    INNOVA 4100 IQ - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)