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Topcon Medical Systems, Inc. recalls Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained he
Recalled February 10, 2021 · FDA recall Z-0952-2021 · Topcon Medical Systems
Hazard
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 · FDA Class II
Units
13 units
Sold at
AZ, MO, NC, NY, PA, TX
Description
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
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.
Manufacturer(s)
Topcon Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →