Recall Z-2591-2017— Merge Healthcare, Inc.

Name: FDA recall Z-2591-2017
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 2019-08-08. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography. Reason: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Terminated: 2019-08-08
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. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography

Reason for recall

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

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