Recall Z-2551-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2551-2016
Creator: U.S. Food and Drug Administration
Published: 2015-07-23

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-07-23, terminated 2016-10-07. It names one FDA 510(k) clearance: K041935. Product: Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) 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 unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Terminated: 2016-10-07
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

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 Z3D software. Merge Unity PACS (formerly DR Systems PACS) 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 unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

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