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 Insight

This FDA Devices action (record #Z-0952-2021) was formally reported on February 10, 2021, with the manufacturer initiating the action on December 18, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Topcon Medical Systems, Inc. is listed as the recalling firm, operating out of Oakland, NJ. Federal records indicate 13 units units are affected.

The documented reason for this recall is: 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 reco… Distribution data in the federal record shows the product reached: AZ, MO, NC, NY, PA, TX. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.