Events

Recall of Device Recall FORUM Archive and Viewer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1049-2015
  • Event Initiated Date
    2015-01-22
  • Event Date Posted
    2015-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133318
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image management, ophthalmic - Product Code NFJ
  • Reason
    Software defect in the forum viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (oct) data.
  • Action
    Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.

Device

Device Recall FORUM Archive and Viewer
  • Model / Serial
    Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1)
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). || Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) || 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); || 000000-2084-928 (USB drive with FORUM 3.2.1) || Ophthalmic image management system.
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG
  • Manufacturer Address
    Carl Zeiss Meditec AG, Carl Zeiss Promenade 10, Jena Germany
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA