Recall Z-1426-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1426-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-08, terminated 2017-03-17. It names one FDA 510(k) clearance: K041935. Product: DR Systems Unity PACS software, now known as Merge Unity PACS. Reason: Reports were missing demographic header information when they were faxed to referring physicians..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Terminated: 2017-03-17
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

DR Systems Unity PACS software, now known as Merge Unity PACS

Reason for recall

Reports were missing demographic header information when they were faxed to referring physicians.

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