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 Welch Allyn.

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 003 10 15 000
  • Event Initiated Date
    2015-10-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8315
  • 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
    Welch allyn has been made aware that the kleenspec 788 corded illuminator has the potential to be incorrectly connected to a c7 type of ac power cord (i.E. iec 60320) instead of being correctly connected to the illuminator dc power cord connector.

Device

KleenSpec Corded illumination System
  • Model / Serial
    Details on affected devices: Model: 78810, 78812, 78814, 78816, 79910, 79912, 79914 and 79916 Affected Devices: All KleenSpec® Corded Illumination Systems can be affected, regardless of lot.
  • Product Description
    illumination System
  • Manufacturer
    Welch Allyn

Manufacturer

Welch Allyn
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA