Events

Recall of WEB VIEWER POCKET VIEWER CELLULAR VIEWER - WEB VIEWER SOFTWARE

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
    70083
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-05
  • 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
    1)possible failure of cic pro alarms.2)mobile care software/mobile viewers do not recognize apexpro fh telemetry transmitter.3)mobile care software/mobile viewers & icentral might generate false positive alarms.

Device

WEB VIEWER POCKET VIEWER CELLULAR VIEWER - WEB VIEWER SOFTWARE
  • Model / Serial
    Model Catalog: M1057669 (Lot serial: S/N'S GB8717D5D4 & GB8747303C); Model Catalog: M1057669 (Lot serial: CZC7520524 & GB8717D5X2); Model Catalog: M1057669 (Lot serial: CZC6394DG9 GB871D5X4)
  • Product Description
    WEB POCKET AND CELLULAR VIEWERS
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)