Events

Recall of SONOSITE TRANSDUCERS FOR HAND-CARRIED ULTRASOUND UNITS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FUJIFILM SONOSITE 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
    21393
  • Event Risk Class
    II
  • Event Initiated Date
    2008-08-26
  • 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
    When attempting to rotate the array from 90 degrees to its upper limit of 180 degreesthe transducer does not advance in single degree increments as expected but will move from 94 degrees directy to 180 degree.

Device

SONOSITE TRANSDUCERS FOR HAND-CARRIED ULTRASOUND UNITS
  • Model / Serial
    Model Catalog: P05183 (Lot serial: n/a)
  • Product Description
    TEE/8-3 MHz Transducer
  • Manufacturer
    FUJIFILM SONOSITE INC.

Manufacturer

FUJIFILM SONOSITE INC.