Events

Recall of COROMETRICS MODEL 170 SERIES FETAL MONITOR

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
    145180
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-04
  • 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
    Some of the corometrics 171 172 173 and 174 series monitors were delivered with the fhr lower alarm limit configured incorrectly at 50 bpm (proper factory default setting is 120 bpm). a lower than expected fhr if left undetected could result in fetal bradycardia and oxygen deprivation to the fetus. there have been no injuries reported as a result of this issue.

Device

COROMETRICS MODEL 170 SERIES FETAL MONITOR
  • Model / Serial
    Model Catalog: 172CAT (Lot serial: > 10 contact mfg); Model Catalog: 172AAT (Lot serial: > 10 contact mfg); Model Catalog: 171MAT (Lot serial: > 10 contact mfg); Model Catalog: 172GAT (Lot serial: > 10 contact mfg)
  • Product Description
    Corometrics 170 Series Monitors
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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