Events

Recall of AKRON and Omega Couch Ranges

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by ArjoHuntleigh 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
    22960
  • Event Initiated Date
    2018-05-10
  • 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: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has received a complaint of a akron tilt table middle section frame breakage. the investigation showed that one of critical welds in the part was missing. please note that not all devices are affected by this defect.
  • Action
    Product to be modified

Device

AKRON and Omega Couch Ranges
  • Model / Serial
    Model: , Affected: Serial numbers within a range between P0167499 and P0418644
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA