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 Medtronic SA.

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 139 07 16 000
  • Event Initiated Date
    2016-07-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9723
  • 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
    1. certain aspects of the technical information in the instructions for use document require clarification. the information to be updated includes system’s specification for x-ray technique factor accuracy, filtration strength, leakage technique factors, air kerma reference location, and tube housing cooling curves. 2. radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements. 3. the o-arm system x-ray technique factor display accuracy related to ma and mas might not be compliant to the system specifications. 4. x-ray generator and motion batteries require inspection to insure they are free from damage during shipment.

Device

O-arm® 1000 and O-arm® O2 Surgical Imaging Systems
  • Model / Serial
    1) O-arm® 1000 Surgical Imaging System: - Model numbers BI-700-00027 and BI-700-00028 2) O-arm® O2 Surgical Imaging System: - Model number BI-700-02000
  • Product Description
    Surgical Imaging device
  • Manufacturer
    Medtronic SA

Manufacturer

Medtronic SA
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA