Events

Recall of Philips Ingenia, Intera and Achieva MR Systems

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
    16740
  • Event Initiated Date
    2014-05-23
  • 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 cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing., the cross reference lines are correctly displayed on the unfused stations., the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images., the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan.
  • Action
    Software to be upgraded

Device

Philips Ingenia, Intera and Achieva MR Systems

Manufacturer

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