Recall Z-0294-2017— Merge Healthcare, Inc.

Name: FDA recall Z-0294-2017
Creator: U.S. Food and Drug Administration
Published: 2011-10-28

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2011-10-28, terminated 2016-12-14. It names one FDA 510(k) clearance: K983401. Product: Fusion Workstation.; Indicated for the transmission and review of radiological images.. Reason: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-10-28
Terminated: 2016-12-14
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K983401 — FRAMEWAVE WEBMl Strategies, Inc.·cleared 1998-12-15

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

Fusion Workstation.; Indicated for the transmission and review of radiological images.

Reason for recall

After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

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