Events

Recall of MYLAB30 GOLD SYSTEM - PHASED ARRAY PROBES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOOTHROYD IMAGING SOLUTIONS 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
    19355
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-11
  • 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
    Using the pa230e transducer with a user-defined setting with the output power to 100% (max) in 2d-tei mode focusing at maximum depth could cause the transducer surface temperature to exceed the maximum allowable limit.

Device

MYLAB30 GOLD SYSTEM - PHASED ARRAY PROBES
  • Model / Serial
    Model Catalog: 9600165000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9600165000 (PA130) (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ESAOTE PA230E TRANSDUCER USED WITH ESAOTE MYLAB SYSTEMS
  • Manufacturer
    BOOTHROYD IMAGING SOLUTIONS INC.

Manufacturer

BOOTHROYD IMAGING SOLUTIONS INC.
  • Manufacturer Address
    GEORGETOWN
  • Source
    HC