Events

Recall of INSTATRAK 3500 PLUS 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
    151165
  • Event Risk Class
    III
  • Event Initiated Date
    2011-03-30
  • 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
    The customer labelling for transmitter sensor cables and receiver sensor cables states that the cables can be sterilized with the sterrad sterilization system. at the initial release of these products the only sterrad method was the 100s model. sterrad has since introduced the 100nx and nx models. the transmitter sensor cable and receiver sensor cable have been validated for sterilization in the sterrad 100s sterilizer and ethylene oxide (eto) sterilizers only. these products have not been validated for use in any other sterrad sterilizer. ge oec medical systems inc. internal testing has shown the high concentration of hydrogen peroxide used in the sterrad 100nx sterilizer is not compatible with some of the materials used in the transmitter sensor cable which may result in the degradation of the material. this could lead to a sterilization issue. testing shows that the receivers are not affected by the change in sterilization.

Device

INSTATRAK 3500 PLUS SYSTEM
  • Model / Serial
    Model Catalog: 1007907-NAV (Lot serial: ALL); Model Catalog: 1007914-NAV (Lot serial: ALL); Model Catalog: 1001989 (Lot serial: ALL); Model Catalog: 1002008 (Lot serial: ALL); Model Catalog: 1001990 (Lot serial: ALL); Model Catalog: 1004069 (Lot serial: ALL)
  • Product Description
    INSTATRAK 3500 PLUS - Sensor Cables
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)