Recall Z-2685-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2685-2016
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 2019-10-15. It names one FDA 510(k) clearance: K053281. Product: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.. Reason: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Terminated: 2019-10-15
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K053281 — EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)Emageon, Inc.·cleared 2005-12-07

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

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.

Reason for recall

Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.

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