Recall Z-1176-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1176-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2019-04-08. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2019-04-08
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082144 — AMICAS PACS, VERSION 6.0Amicas, Inc.·cleared 2008-09-05

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

Reason for recall

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

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