Events

Recall of RMS SIMBA Buggy

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Rehabilitation Manufacturing Services 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
    18121
  • Event Initiated Date
    2015-02-18
  • 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: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
  • Reason
    Manufacturer has been made aware that frame components are substandard and have the potential to fail in use potentailly endangering the health of the user. the frame knuckle joints, found on each side of the simba logo sticker, have been produced using an incorrect method of manufacture causing a reduction in component strength and must be replaced to ensure continued safe use of the product.
  • Action
    Product to be exchanged

Device

RMS SIMBA Buggy

Manufacturer

Rehabilitation Manufacturing Services Ltd