# FDA recall Z-1138-2019

> **Topcon Medical Systems, Inc.** · Class II · device recall initiated 2019-03-06.

## Product

IMAGEnet 6 v1.53-   IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without  controlling or altering the functions and parameters of any medical devices or through computerized networks.

## Reason for recall

When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1138-2019
- **Recalling firm:** Topcon Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-06
- **Report date:** 2019-04-24
- **Termination date:** 2019-07-17

- **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-1138-2019

## Citation

> AI Analytics. FDA recall Z-1138-2019. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1138-2019. Source: US FDA. Licensed CC0.

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