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 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
    146000
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-20
  • 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
    Hill-rom has received thirteen reports over the past 8 year from facilities in the usa alleging that the affinity four lift-off foot section has fallen resulting in three minor injuries. analysis suggests that the latch mechanism may have been bent due to user error during handling of the foot section such as dropping it to the floor.

Device

AFFINITY FOUR BIRTHING BEDS P3700B
  • Model / Serial
    Model Catalog: P3700B (Lot serial: n/a)
  • Product Description
    AFFINITY FOUR BIRTHING BEDS P3700B
  • Manufacturer
    HILL-ROM CANADA LTD.

Manufacturer

HILL-ROM CANADA LTD.