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 SIEMENS.

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 024 08 18 001
  • Event Initiated Date
    2018-11-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13445
  • 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
    Due to a problem with the steel cables inside the lifting column of the overhead tube, the steel cables may rupture. the probability of occurrence depends on the degree of usage of the system and is rated as extremely rare. in case the cables break, the tube arm may fall down unexpectedly during movement in vertical direction.

Device

Ysio and Ysio MAX systems and Multix Fusion Analog , Multix Fusion Digital Portable , Multix Fusi...
  • Model / Serial
    Ysio (model number 10281013 or 10281163) Ysio MAX (model number 10762470) System Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059) Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042) Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042) Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042) FDA Update Codes: AXIOM Multix MT (model number 8395415 or 8395399 or 8395381) Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119
  • Product Description
    Stationary basic diagnostic x-ray system, digital
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA