CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report
Harmony Referral System (aka Harmony RS)/ Medical Device Data System recalled
Topcon Medical Systems is recalling Harmony Referral System (aka Harmony RS)/ Medical Device Data System, distributed in Arizona, Missouri, North Carolina, New York, Pennsylvania, Texas. The recall was initiated on 18 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0952-2021
- FDA event ID
- 87086
- Recalling firm
- Topcon Medical Systems, Oakland, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2020
- FDA classified
- 4 Feb 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2020 | Recall initiated by company | |
| 4 Feb 2021 | Classified by FDA | +48 days |
| 10 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
AZ, MO, NC, NY, PA, TX
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Software Version 3.1
Where was it sold?
AZ, MO, NC, NY, PA, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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