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 Nihon Kohden Corp.

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 008 02 11 000
  • Event Initiated Date
    2011-02-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=109
  • 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
    A fault in the lock plate of the cart, some lock plate are not thick enough to support the monitor under condition of frequent tilting. in a worst-case situation, the monitor can fall over.

Device

KC 600P Cart, beside Monitor
  • Model / Serial
    WEP 5200 Telemetry System, BSM 6000 series or PVM 2701 Beside Monitor attached to KC 600P Cart
  • Product Description
    Monitors, Bedside, Physiologic
  • Manufacturer
    Nihon Kohden Corp

Manufacturer

Nihon Kohden Corp
  • Manufacturer Parent Company (2017)
    Nihon Kohden Corp.
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB, Riyadh (01) 4793000
  • Source
    SFDA