Events

Recall of Allen Patient Supports

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Allen Medical Systems 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
    22277
  • Event Initiated Date
    2017-11-23
  • 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: Denyers (NZ) Ltd, 27 William Pickering Drive, Albany, Northshore, Auckland 0742
  • Reason
    The manufacturer has become aware of a potential risk, which could result in critical harm to the patient if the base of the bow frame were to crack during use. since the introduction of this product in march 2017, one complaint with no allegation of injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • Action
    Product to be modified

Device

Allen Patient Supports

Manufacturer

Allen Medical Systems Inc