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 Handicare AB.

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 212 08 15 000
  • Event Initiated Date
    2015-08-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=8165
  • 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
    Transition gate manual is used to connect two rails in a ceiling lift system. typically it connects a single rail to a traverse system. the design of transition gate manual forces the safety pins in the gate to their upper, open, position when the rails are aligned and ensures that the safety pins are pushed back to their lower, closed, positions when the rails are pulled apart. if the safety pin is pushed repeatedly by one of the trolley types mentioned above, the wiggling of the trolley will cause a movement of the safety pin upwards . this can only occur if transition gate manual is used in combination with the types of trolleys specified above, and with a low load or non-load onto the lift. the friction between the bushing and the safety pin can hinder the pin from falling down by itself, leaving the rail open and allowing the trolley to pass and fall to the floor.

Device

Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37
  • Model / Serial
    Model: 50400226, 50400237, 50400238 See attached FSN
  • Product Description
    Stationary patient lifting system, line-powered
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB
  • Manufacturer Parent Company (2017)
    Handicare Group Ab
  • Manufacturers representative
    Al Safwa Dimensions
  • Source
    SFDA