Lower riskMedical device recall · FDA · Published December 18, 2020
Topcon Harmony RS Software: Risk of Merging Patient Records
Topcon Medical Systems recalls Harmony RS software version 3.1 due to risk of combining patient records when using with specific medical devices. Affected healthcare professionals should contact for remedy.
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
Take action
Contact the company
📍Recalling firmTopcon Medical Systems, Inc.111 Bauer Dr · Oakland, NJ 07436-3123
“Topcon Harmony RS Software: Risk of Merging Patient Records.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63641-topcon-harmony-rs-software-risk-of-merging-patient-records. Based on FDA recall #Z-0952-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0952-2021%22&limit=1).
The FDA announced on Dec. 18, 2020, that Topcon Medical Systems is recalling the Harmony Referral System due to a hazard where non-unique patient IDs caused multiple records to be combined. The voluntary Class II recall affects 13 units distributed in six states.
How to tell if you have it
Brand: Topcon Medical Systems
Product: Harmony Referral System (aka Harmony RS)/ Medical Device Data System
Software Version: 3.1
Quantity: 13 units
The hazard
The hazard involves integrations with Topcon equipment, TRC NW-400 and the Signal Camera that allowed user input of non-unique patient IDs. This error caused multiple patient records and images to be combined under the first generated record.
Context
GovInfoNow's records show Topcon Medical Systems has two other recalls on record since March 6, 2019, including a Sept. 17, 2024 recall for incorrect visual field analysis risk and a March 6, 2019 recall for patient data display hazards. Other recent recalls of similar products include the July 31, 2026 GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall, the July 31, 2026 GE Healthcare Enterprise Archive V8 Software Recall, and the July 31, 2026 GE Healthcare Centricity PACS Software Recall.
How to tell if you have this one
The Harmony RS software version 3.1, used with Topcon equipment such as the TRC NW-400 and Signal Camera. This software is intended for healthcare professionals to access patient information.
Brand
Topcon Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify if you have Harmony RS software version 3.1 that integrates with Topcon equipment like the TRC NW-400 and Signal Camera.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “AZ, MO, NC, NY, PA, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Missouri, New York, North Carolina, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0952-2021 (December 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0952-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.