Events

Recall of MODEL 259 MATERNAL/FETAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    55606
  • Event Risk Class
    II
  • Event Initiated Date
    2008-12-14
  • 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
    Dislodging/disconnecting of the ground clip resulting in loss of ground connection for the ultrasound bezel connector.

Device

MODEL 259 MATERNAL/FETAL
  • Model / Serial
    Model Catalog: 259AXY-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 259AXC-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 259AAC-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 259ACC-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 259AAY-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 259ACY-AAAA (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    COROMETRICS 250 SERIES MATERNAL/FETAL
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC