# FDA recall Z-0952-2021

> **Topcon Medical Systems, Inc.** · Class II · device recall initiated 2020-12-18.

## 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

## Distribution

AZ, MO, NC, NY, PA, TX

## Key facts

- **Recall number:** Z-0952-2021
- **Recalling firm:** Topcon Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-02-10
- **Termination date:** 2022-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oakland, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2021

## Citation

> AI Analytics. FDA recall Z-0952-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0952-2021. Source: US FDA. Licensed CC0.

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