Z-0952-2021Class II

Harmony Referral System (aka Harmony RS)/ Medical Device Data System -

Name: Z-0952-2021 Harmony Referral System (aka Harmony RS)/ Medical Device Data System -
Creator: Topcon Medical Systems, Inc.
Published: 2020-12-18
License: https://open.fda.gov/license/

Topcon Healthcare, Inc. / initiated 2020-12-18 / Terminated / root cause: software

FDA source

Topcon Medical Systems, Inc. began a recall of Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to... on 2020-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0952-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-02-04
Terminated: 2022-10-19
Recalling firm: Topcon Healthcare, Inc.
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.
Product code: NFJ System, Image Management, Ophthalmic
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
Root cause tag: software
FDA root cause: Software design
Action: Topcon issued Urgent Medical Device Correction letter on 12/18/20 via email. Letter states reason for recall, health risk and action to take: Topcon Healthcare will determine original patient demographics from the image database. Using the originally entered patient information Topcon Healthcare will reprocess the merged patient recordsand images and form a unique ID by combining the ID, first & last name and date of birth. (i.e. 12345/John Doe/19860120). Customer Care team will be contacting you by phone prior to the December 22nd database correction to further describe the process and help with any questions that you may have. If you have any concerns, or would speak to Topcon Healthcare prior to this call, please feel free to contact us at 866-922-6278 (option 2).
Quantity in commerce: 13 units
Distribution: AZ, MO, NC, NY, PA, TX
Product codes and lots: Software Version 3.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0952-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0952-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-04

Product code NFJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)