Events

Retiro De Equipo O Alerta De Seguridad para RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Clarity Medical Systems, Inc., UNITED STATES OF AMERICA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    ИМ-7.99401
  • Fecha
    2014-04-03
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Notas adicionales en la data
  • Causa
    Clarity medical systems, inc. recently identified the incorrect operation of the three software versions (version 6.0, 6.1 and 6.2). under certain conditions, the display may show the calculated value of the patient's age, which is 2 weeks less than the actual age. this miscalculation occurs at regular intervals, does not affect the date of birth entered, and has no effect on any other functions of the retcam system. what to do: 1. do not rely on the calculated age of the patient with the retcam system. 2. use the entered date of birth. 3. any medical decisions (for example, screening dates) that were based on the age calculated by the retcam system should be revised. currently, the company is developing a software solution to eliminate the identified deficiency, the results will be announced later.

Device

RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

Manufacturer

Clarity Medical Systems, Inc., UNITED STATES OF AMERICA