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 121 07 18 000
  • Event Initiated Date
    2018-07-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12959
  • 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 received a complaint reporting that a monitor ceiling suspension (mcs) with a flexvision 56-inch large screen fell to the ground. the actuator assembly of the mcs became detached and the monitor carriage with the flexvision monitor dropped to the ground. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient table when not in use. (parked position).

Device

Allura Xper, integris systems.
  • Model / Serial
    All systems mentioned in the attached file that were delivered with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 201 1 are affected. Allura Xper FD10 C : 722001 Allura Xper FD10 F : 722002 - Please check attachment for all AFFECTED PRODUCTS -
  • Product Description
    Monitor Ceiling Suspension (MCS)
  • Manufacturer
    Philips Healthcare

Manufacturer

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