Events

Rappel Ou Alerte De Sécurité sur RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

Selon Ministry of Health of the Republic of Belarus, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à Belarus qui a été fabriqué par Clarity Medical Systems, Inc., UNITED STATES OF AMERICA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Safety alert
  • Numéro de l'événement
    ИМ-7.99401
  • Date
    2014-04-03
  • Pays de l'événement
    Belarus
  • Source de l'événement
    MHRB
  • URL de la source de l'événement
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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