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 V.Guldmann A/S.

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 110 04 12 000
  • Event Initiated Date
    2012-04-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1741
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The gh3 trolley can fall down, in case of the hoist is placed straight underneath the safety lock (the safety device of the combi lock) and then the staff activate the combi lock the safety lock is closing the rail, preventing the hoist moving out of the rail, when the traverse rail moves away from the fixed rail. under this special circumstance and the hoist is moved extremely sideways to get the traverse rail free of the combi lock the safety lock can be bypassed, and the hoist can move out of the rail.

Device

Ceiling hoist, Trolley sets, GH3/GH1 Trolley
  • Model / Serial
    Model number: 550097; Serial no.: All Lot/batch no.: All
  • Product Description
    Ceiling hoist, Trolley sets
  • Manufacturer
    V.Guldmann A/S

Manufacturer

V.Guldmann A/S