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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 with any questions that you may have. If you have any concerns, or would speak to Topcon Healthcare prior to this call, please feel free to contact us at 866-922-6278 (option 2).

Distribution

As reported by FDA

AZ, MO, NY, NC, PA, TX