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 Stryker Communications.

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 051 05 13 000
  • Event Initiated Date
    2013-05-15
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3603
  • 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
    Sources utilizing s-video and composite inputs, phase alternating line (pal) signals appear with jagged edges on all diagonal lines resulting in poor video quality.

Device

Router and Control System , Switchpoint Infinity 3 (SPI3)
  • Model / Serial
    (Name : ASSY, SPI3, SOl - VIDEO RX . Part No : 0100224713 ) ( Name : PKG, SWITCHPOINT INFINITY 3 . Part No : 0678001000 ) ( Name : REPAIR KIT, SPI3, SOl AND VIDEO RECEIVE (PIN) . Part No : 0678001052) ( Name : UPGRADE KIT, SPI3, VIDEO RX . Part No : 0678001127 )
  • Product Description
    Switchpoint Infinity 3 (SPI3) Router and Control System (Figure.1) is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel
  • Manufacturer
    Stryker Communications

Manufacturer

Stryker Communications
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119999
  • Source
    SFDA