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 Ergolet A/S.

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 081 04 12 000
  • Event Initiated Date
    2012-04-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1712
  • 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
    Due to an incident and several claims regarding broken gas springs on the hera ii, and after specific risk analysis, ergolet has decided that replacement of the gas spring is necessary. the back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. if a patient is seated in the chair during this malfunction, there is a risk of the patient hurting the back of the head or getting injured in the neck by the sudden backwards movement.

Device

Bathing & Toileting chair, Ergolet Hera II
  • Model / Serial
    Model number: 041-00250, 041-00255, 041-00256, 041-00280, 041-00281; S/N: 1379 to 2180
  • Product Description
    Bathing & Toileting chair
  • Manufacturer
    Ergolet A/S

Manufacturer

Ergolet A/S