Events

Recall of SonoSite Universal PowerPark Stand Module

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    18329
  • Event Initiated Date
    2015-04-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Sonosite Australasia Pty Ltd (New Zealand), 81 Clonbern Road, Remuera, Auckland 1541
  • Reason
    During the manufacturing process of the stand module an incorrect component was used. this component leaves the affected stand module out of specification.
  • Action
    Product to be modified

Device

SonoSite Universal PowerPark Stand Module
  • Model / Serial
    Model: Part Numbers: P12822-25, P12822-26, Affected: Manufacturing date range: Jul-2012 through Dec-2014
  • Manufacturer
    Fujifilm SonoSite Inc

Manufacturer

Fujifilm SonoSite Inc