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