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 Intuitive Surgical 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 156 06 15 000
  • Event Initiated Date
    2015-06-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7875
  • 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 purpose of this letter is to advise you that intuitive surgical is initiating a voluntary correction related to the da vinci xi reprocessing manuals for the endowrist instruments.

Device

da Vinci Xi Endowrist Instruments
  • Model / Serial
    Not specific to a lot or lots of product. All EndoWrist instruments used with the da Vinci Xi Surgical System and covered by the following user manuals : Czech 552286-01 553262-01 Dutch 552288-01 553265-01 English 551708-01 552898-01, 552628-01 French 552291-01 553267-01 German 552292-01 553268-01 Italian 552296-01 553269-01 Korean 552298-01 553270-01 Norwegian 552301-01 553271-01 Romanian 552304-01 553307-01 Spanish 552309-01 553273-01 Swedish 552310-01 553274-01 Traditional Chinese 552284-01 553263-01 Turkish 552311-01 553275-01
  • Product Description
    Endotherapy electrosurgical diathermy system electrode, reusable
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Manufacturers representative
    Gulf Medical Co, Jeddah (012)6512828
  • Source
    SFDA