Events

Recall of Hill-Rom Affinity 4 Birthing Bed

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hill-Rom 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
    16973
  • Event Initiated Date
    2014-07-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Reason
    Hill-rom would like to remind users of proper handling of the lift-off foot section per the affinity four birthing bed manual. improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. if the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. if the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
  • Action
    Product to be modified

Device

Hill-Rom Affinity 4 Birthing Bed
  • Model / Serial
    Model: Part Number: P3700B/C/D/E, Affected: Manfactured between Oct-2006 and Jun-2014
  • Manufacturer
    Hill-Rom Inc

Manufacturer

Hill-Rom Inc