FDA Device recall Z-0952-2021
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professiona…
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professiona… by Topcon Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0952-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-18 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Topcon Medical Systems |
| Distribution | AZ, MO, NC, NY, PA, TX |
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.
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
Identifiers
| code_info | Software Version 3.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0952-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.