Recall – Medical archive system allowed non-unique patient IDs

Company: Topcon Medical Systems, Inc.
Date of Enforcement Report: 2/10/2021
Class II


Harmony Referral System (aka Harmony RS)/ Medical Device Data System – Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.

Recall Number: Z-0952-2021


Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record.


Topcon Medical Systems, Inc. on 12/18/2020. Voluntary:  Firm Initiated recall is ongoing.


13 units


U.S. Nationwide

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15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.