Events

Recall of Low rise bed - Ningbo

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ningbo Kangmailong Medical Apparatus Co. 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
    21930
  • Event Initiated Date
    2017-09-08
  • 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: Pride Mobility Products New Zealand Limited, 38 Lansford Crescent, Avondale, Auckland
  • Reason
    The side rails supplied with the beds do not comply with the standard iec 60601-2-52:2009: medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds and there is a risk of patient harm, including but not limited to patient entrapment.
  • Action
    Product to be exchanged

Device

Low rise bed - Ningbo

Manufacturer

Ningbo Kangmailong Medical Apparatus Co. Ltd