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 094 12 18 000
  • Event Initiated Date
    2018-12-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13664
  • 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 mr systems are standard equipped with two ceiling speakers, positioned in the front and/or rear of the mr system. these speakers enable communication between the operator in the examination room and the patient and offer stereo music or ambient experience audio. these speakers are in most cases fixated in the suspended ceiling of the mr examination room according the philips service instructions. the philips planning reference data (prd) prescribes the suspended ceiling must be strong enough to hold 25 n speakers. however in very rare cases, due to external influences (hospital facility maintenance, water leakage, degradation of speaker fixation) during the lifetime of the mr system, the ceiling speaker(s) could fall from their position and be pulled to the mr system by the magnetic field.

Device

Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, Smart...
  • Model / Serial
    Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR OR, MR-RT, MR-Linac, MR-Marlin systems
  • Product Description
    MRI systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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