Events

Recall of Philips Extended Brilliance Workstation (EBW)

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 (USA).

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
    13725
  • Event Initiated Date
    2012-10-29
  • 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 advises that specific versions of ebw software may cause an incorrect display of patient information/annotation and may lead to misinterpretation. specifically:, 1) when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately., 2) in the calcium scoring (cs) protocol, the protocol is switched to mass score but the protocol name remains agatston., 3) spline measurement values do not update when adding control point (cp) and when changing the length of the line., 4) in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct suv values., 5) loading pet images in the ct viewer (ctv) \ quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • Action
    Software to be upgraded

Device

Philips Extended Brilliance Workstation (EBW)
  • Model / Serial
    Model: , Affected: Versions 4.0.2, 4.5.2 and 4.5.3 SNs: 12314, 13160, 14329, 14674 ,12142 and 13348
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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