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 Trumpf Medical Systems, Inc..

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 049 04 16 000
  • Event Initiated Date
    2016-04-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9177
  • 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
    The universal arm support enables precise positioning of the patient’s arm during surgical procedures. during our continuous monitoring and analysis of trumpf medical products installed in the field customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. the feedback describes the issue occurring while attempting to secure the position of the device. with this preventive field action trumpf medical proactively wants to ensure the safe intended use of the universal arm support. the product has not been involved with any reported injuries.

Device

Universal Arm Support
  • Model / Serial
    Product Name: Universal Arm Support 450 Model Number: 1697630 up to serial number: 102441510 Product Name: Universal Arm Support 450 T Model Number: 1697635 up to serial number: 102472407 Product Name: Universal Arm Support 600 Model Number: 1697639 up to serial number: 102406761 Product Name: Universal Arm Support 600 T Model Number: 1697651 up to serial number: 102412823 Product Name: Universal Arm Support 450 U Model Number: 1697660 up to serial number: 102426024 Product Name: Universal Arm Support 450 U T Model Number: 1697662 up to serial number: 102452250
  • Product Description
    Arm Support
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA