Recall Z-2531-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2531-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-30

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-01-30, terminated 2021-05-07. It names 3 FDA 510(k) clearances: K092915, K082144, K033825. Product: iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.. Reason: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Terminated: 2021-05-07
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K092915 — CEDARA WEBACCESS, MODEL: 2.4Cedara Software Corp.·cleared 2010-06-23
K082144 — AMICAS PACS, VERSION 6.0Amicas, Inc.·cleared 2008-09-05
K033825 — ORTHOPACSEtrauma.Com Corp.·cleared 2004-02-02

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

iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

Reason for recall

Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

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