Events

Recall of Philips MultiDiagnost Eleva

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems Nederland BV.

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
    22831
  • Event Initiated Date
    2018-04-18
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    The manufacturer has become aware that the fixation of the upper and lower tilt actuator of the md-eleva system might break off and the table will start to rotate from 0 to + 90 / - 90 degrees with high speed if the point of gravity of the table is beyond its rotation point. this rotating movement can not be stopped by the user, which potentially could lead to the patient falling off the table.
  • Action
    Product to be modified

Device

Philips MultiDiagnost Eleva
  • Model / Serial
    Model: MultiDiagnost Eleva 708032, MultiDiagnost Eleva with Flat Detector 708034, MultiDiagnost Eleva with Flat Detector 708038, Affected:
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA