Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0952-2021 — 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.

U.S. FDA — Device Enforcement · United States · 2020-12-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0952-2021
Date of alert: 2020-12-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Topcon Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0952-2021 — 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.

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