Events

Recall of AFFINITY FOUR BIRTHING BEDS P3700B

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HILL-ROM CANADA.

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
    92689
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-16
  • 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
    4 warning labels on the affinity four birthing bed where each warning label contains english text or had english text with an international symbol. in accordance with quebec provincial code all labels is to be in french.

Device

AFFINITY FOUR BIRTHING BEDS P3700B
  • Model / Serial
    Model Catalog: P3700B (Lot serial: H331AA4785 TO J157AA9005)
  • Product Description
    P3700B AFFINITY FOUR BIRTHING BEDS
  • Manufacturer
    HILL-ROM CANADA

Manufacturer

HILL-ROM CANADA