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 052 09 15 002
  • Event Initiated Date
    2015-12-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8618
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Philips healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1 .C.

Device

Allura Xper FD
  • Model / Serial
    Product codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059 ........................ Swissmedic update codes : Systems: Allura Xper FD R1.2.8 Product codes: 722001, 722002, 722003 .................... MHRA update code Systems: All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.x where x<9, or 2.0.x where x<9, or 3.1.x or 4.3.x or 5.0.x or 6.0.x or 7.0.x or 7.2.x where x<8 or 7.6.x or 7.7.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16 All Allura Centron systems with software releases lower than 1.0.2.1 and all CV20 systems with software release 6.5.x where x<3 Product codes: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722022, 722023, 722025, 722026, 722400
  • Product Description
    Radiographic/Fluoroscopic Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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