Recall Z-3105-2017— Merge Healthcare, Inc.

Name: FDA recall Z-3105-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-14

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2017-08-14, terminated 2019-05-08. It names 2 FDA 510(k) clearances: K143318, K041935. Product: 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 medical images from a variety of diagnostic imaging systems. Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Terminated: 2019-05-08
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K143318 — DR Systems Zero Download 3D Viewer (Z3D)Dr Systems, Inc.·cleared 2015-03-10
K041935 — DR SYSTEMS PACS, RELEASE 6.1Dr Systems, Inc.·cleared 2004-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 medical images from a variety of diagnostic imaging systems

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.