Events

Recall of AIXPLORER ULTRASOUND SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHRISTIE INNOMED INC..

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
    17251
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-09
  • 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 problem occurs within the aixplorer v4.2 software when using the tamv (time average mean velocity) tool in pw mode. when used under certain conditions the calculation of the mean velocity value deduced from the peak value could be erroneous. therefore the tamv calculation displayed on the monitor is incorrect.

Device

AIXPLORER ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: SSIP90019 (Lot serial: SIB5127); Model Catalog: SSIP90019 (Lot serial: SIB5128); Model Catalog: SSIP90019 (Lot serial: SIB5129); Model Catalog: SSIP90019 (Lot serial: SID0918); Model Catalog: SSIP90019 (Lot serial: SID2531); Model Catalog: SSIP90019 (Lot serial: SIC4724)
  • Product Description
    Aixplorer Ultrasound System - Main Unit
  • Manufacturer
    CHRISTIE INNOMED INC.

Manufacturer

CHRISTIE INNOMED INC.