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 001 04 12 000
  • Event Initiated Date
    2012-04-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1632
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Philips healthcare has received reports of three occurrences where the monitor ceiling suspension system fell to its lowest position. in one occasion it collided with the table top. no patient harm has been reported. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs.

Device

Radiographic/Fluoroscopic Systems
  • Model / Serial
    System: Allura Systems FD10 , FD20, FD10/10, FD20/10 and FD20/20 (*) shipped between November 15th 2011 and March 15th 2012 that include an Actuator with an assembly error (Actuator Short Assy: 989600-184-665 and Actuator Long Assy: 989600-184-654). A limited number of Allura Sytems (3 FD10 and 1 FD20/20) (**) in which the Actuator has been replaced by an Actuator with an assembly error. (*) Productcodes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025 (**) Product codes: 722001, 722003 and 722008
  • Product Description
    Radiographic/Fluoroscopic Systems, Angiography/Interventional
  • Manufacturer
    Philips Healthcare

Manufacturer

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