Topcon Medical Systems, Inc. Recall 87086
Description: 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.
Topcon Medical Systems, Inc. Recall 87086 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0952-2021 |
| Event ID | 87086 |
| Event Description | 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 Type | Devices |
| Distribution | AZ, MO, NC, NY, PA, TX |
| Quantity | 13 units |
| Recall Reason | 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 |
| Device Classification | 20210210 |
| Device Code Info | Software Version 3.1 |
| Center Classification Date | 20210204 |
| Recall Initiation Date | 20201218 |
| Recalling Firm | Topcon Medical Systems, Inc. |
| Initial Notification | |
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