Events

Recall of AVALON FETAL MONITOR FM20 - MAIN UNIT

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
    9893
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-10
  • 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
    This problem affects revision c and d of the software. in rare circumstances the settings for paper scale type and recorder speed may revert back to the factory default settings which are: us paper style and 3 cm/min paper speed. this behaviour would have the most impact in europe and asia/pacific where other settings are preferred. if this change remains undectected by the user it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. the problem occurs when the power-up/boot sequence of the fetal monitor is interrupted e.G. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.

Device

AVALON FETAL MONITOR FM20 - MAIN UNIT
  • Model / Serial
    Model Catalog: M2702A (Lot serial: DE53001002 THROUGH DE53107383); Model Catalog: M2703A (Lot serial: DE53001002 THROUGH DE53107383)
  • Product Description
    AVALON FETAL MONITOR FM20-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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