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 099 11 18 000
  • Event Initiated Date
    2018-11-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13548
  • 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
    The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. information to assist you in identifying whether you have an impacted software version is provided in this communication. if the incorrect software version is loaded on the brivo mr355, optima 360, signa profile, signa ovation hd, signa ovation .35t, signa hfo, signa hde, signa ovation with excite, 0.7t signa openspeed, signa infinity with excite technology, signa excite 3t and 1.5t signa hdxt systems the images can be flipped left/right and/or there can be patient data mismatch.

Device

Multiple GE MRI systems
  • Model / Serial
    This correction applies to some units of the following GE Healthcare MRI system types: Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite & 0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDxt, Brivo MR355 & Optima MR360, Signa Creator & Signa Explorer.
  • Product Description
    MRI systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare