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 GE 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 124 10 16 000
  • Event Initiated Date
    2016-10-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10102
  • 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
    Screws from the “heater head” of the lullaby warmer may come loose over time and could fall onto the bed. this situation can be clinically hazardous because potential thermal injury to a patient could result.

Device

Lullaby Warmer
  • Model / Serial
    Affected model numbers: Lullaby warmer 230 V, Lullaby warmer 115 V Lullaby warmer part numbers: 2041599-001, 230 V and 2060092-001, 230 V 2050878-001, 115 V and 2061755-001, 115 V
  • Product Description
    Infant Warmer
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare