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

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 — recall Z-3105-2017

U.S. FDA — Device Enforcement · United States · 2017-08-14 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3105-2017
Date of alert: 2017-08-14
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Related