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 Verathon 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 016 06 13 000
  • Event Initiated Date
    2013-06-04
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3695
  • 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
    May break during use.

Device

GlideScope Reusable AVL, GVL, and Ranger Laryngoscope Blades
  • Model / Serial
    Section 1– discontinue use for the following GlideScope Video Laryngoscope Blades; Product name: AVL2 Part Nos.:0574-0118 Serial Nos.: AC111500 through AC121604 Product name: AVL3 Part Nos.: 0574-0115 Serial Nos.: AD111500 through AD121688 Product name: AVL4 Part Nos.: 0574-0116 Serial Nos.: AE111500 through AE121778 Product name: AVL5 Part Nos.: 0574-0117 Serial Nos.: AF111500 through AF121666 Product name: GVL3 Part Nos.: 0574-0007 Serial Nos.: MD112388 through MD121908 Product name: GVL4 Part Nos.: 0574-0001 Serial Nos.: LG112759 through LG122582 Product name: GVL5 Part Nos.: 0574-0030 Serial Nos.: XL111799 through XL121759 Section 2– monitor for wear or damage for the following GlideScope Video Laryngoscope Blades: Product Name: AVL2 Part Nos.:0574-0118 Serial Nos.: All serial numbers
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Laryngoscope Blades
  • Manufacturer
    Verathon Inc

Manufacturer

Verathon Inc
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Manufacturers representative
    Techno-Orbits Establishment, Riyadh, (01) 2293 142
  • Source
    SFDA