Events

Recall of SONALLEVE MR-HIFU FIBROID THERAPY SYSTEM - 3.0T

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    20758
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-03
  • 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 performing sonication with the sonalleve mr-hifu fibroid therapy system (with r2.1 l3 application software) with treatment cells of 2mm in size there is a possibility that the depth of sonication is not shown on the user interface due to a software defect. a maximum positioning error of 4cm in longitudinal direction is possible. this may occur either in the uterine fibroid or the bone application.

Device

SONALLEVE MR-HIFU FIBROID THERAPY SYSTEM - 3.0T
  • Model / Serial
    Model Catalog: 994996 (Lot serial: 6115); Model Catalog: 994996 (Lot serial: 6102)
  • Product Description
    SONALLEVE MR-HIFU FIBROID THERAPY
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC