Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Philips Healthcare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 075 08 14 001
  • Event Initiated Date
    2014-08-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6318
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129099
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Problem 1: when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed should be the same as the ejection fraction (ef) originally displayed when the bookmark was first created. in some instances, the ejection fraction (ef) may be different. problem 2: when processing using one of the following nm clinical applications: autoquant, emory cardiac toolbox, corridor4dm, or neuroq, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. problem 3: while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. problem 4: while displaying pet images within ct viewer, the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi- modality tumor tracking applications. the expected behavior in such a case is that the application displays a warning that suv cannot be calculated due to missing information, and the images are displayed with the original acquisition units (bq/ml). instead, in affected systems, if the patient height has not been entered and the selected suv calculation method requires height data (i.E., suv-bsa), the system may display an suv calculated using a different method (suv-bw) without providing any warning that required data had not been entered or informing the user of the change.

Device

IntelliSpace Portal Software Versions 5 and 6
  • Model / Serial
    - IntelliSpace Portal DX/HX/EX, Software Versions 5 and 6 - IntelliSpace Portal IX, Software Versions 5 and 6 - IntelliSpace Portal LX SPECT, Software Versions 5 and 6 ………………………………….. Update code from FDA : - Please check attached file for lot numbers –
  • Product Description
    Workstations for Medical Imaging Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA