Recall Z-2590-2017— Merge Healthcare, Inc.

Name: FDA recall Z-2590-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-08

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2017-05-08, terminated 2019-08-05. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Terminated: 2019-08-05
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

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

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