Events

Recall of AVALON FETAL MONITOR FM30 - 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
    52740
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-18
  • 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
    Philips has received a number of complaints of inaccurate ultrasound-derived fetal heart rate readings from users of the philips avalon fetal monitors (models fm20 fm30 fm40 and fm50). although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring the frequency of such complaints is greater for these devices than for the previous-generation philips series 50 fetal monitors. clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to perform unnecessary interventions such as caesarean delivery fail to identify the need for interventions or fail to identify fetal distress.

Device

AVALON FETAL MONITOR FM30 - MAIN UNIT
  • Model / Serial
    Model Catalog: M2703A (Lot serial: > 100 Numbers contact mfg); Model Catalog: M2704A (Lot serial: DE81001152); Model Catalog: M2702A (Lot serial: > 10 numbers contact mfg); Model Catalog: M2705A (Lot serial: > 10 numbers contact mfg)
  • Product Description
    AVALON FETAL MONITOR FM30 - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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