Recall Z-2601-2017— Merge Healthcare, Inc.

Name: FDA recall Z-2601-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-24

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2017-05-24, terminated 2019-10-15. It names 3 FDA 510(k) clearances: K092915, K082144, K022881. Product: Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-24
Terminated: 2019-10-15
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
K022881 — CEDARA I-SOFTVIEWCedara Software Corp.·cleared 2002-10-22

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 OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason for recall

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

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