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 Baxter Healthcare.

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 075 06 17 000
  • Event Initiated Date
    2017-06-22
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11208
  • 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
    Baxter healthcare is issuing an urgent device correction for the ak 98 hemodialysis machines listed above. baxter has identified that an incorrect cable was installed in the affected ak 98 machines. the non-compliant cable may cause current leakages higher than specified values if continuously connected to a network during treatment. these units do not have, and are not intended to have, ethernet functionality.

Device

AK 98, 230V, Bio
  • Model / Serial
    Product code(s): 115248, Serial numbers 13320 and lower
  • Product Description
    Hemodialysis machines
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA