Events

Recall Or Safety Alert for RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Clarity Medical Systems, Inc., UNITED STATES OF AMERICA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety alert
  • Event Number
    ИМ-7.99401
  • Date
    2014-04-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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