Recall Z-0952-2021 ยท NFJ System, Image Management, Ophthalmic
Topcon Medical Systems, Inc.
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.
| Date | Dec 18, 2020 |
| Status | Terminated |
| 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 |
| 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 w |
| Quantity | 13 units |
| Distribution | AZ, MO, NC, NY, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.