Harmony Referral System — Class II medical device recall Z-0952-2021
Terminated recall by Topcon Medical Systems, Inc., reported 2021-02-10, distributed in AZ, MO, NC, NY, PA, TX. Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-uni
| Recall number | Z-0952-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Topcon Medical Systems, Inc., Oakland, NJ, United States |
| Recall initiated | 2020-12-18 |
| Classified | 2021-02-04 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2022-10-19 |
| Distributed | AZ, MO, NC, NY, PA, TX |
| Quantity | 13 units |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0952-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.