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

PRODUCT

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

REASON

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.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

13 units

DISTRIBUTION

U.S. Nationwide