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

Recall Z-2566-2018 — Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of

U.S. FDA — Device Enforcement · United States · 2017-08-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2566-2018
Date of alert: 2017-08-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merge Healthcare, Inc.
Product category: device
Product type: Devices

Reported risk: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

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.

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