Events

Recall of Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Handicare AB.

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
    16761
  • Event Initiated Date
    2014-07-28
  • 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: Active Rehab Equipment, 25 Rennie Drive, Airport Oaks, Auckland
  • Reason
    During the period april 2009 to may 2011, handicare ab used a wing handle in which the screw and the handle, after repeated tightening, may slide apart. this causes a small play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. eventually this may cause mechanical fatigue in the material of the ladder.
  • Action
    Product to be modified

Device

Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device
  • Model / Serial
    Model: Models 7400 and 7500, Affected: Manufactured between Apr-2009 and May 2011
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB