Recall Z-0611-2017— Merge Healthcare, Inc.

Name: FDA recall Z-0611-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-25

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-05-25, terminated 2019-08-28. It names one FDA 510(k) clearance: K092915. Product: iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-25
Terminated: 2019-08-28
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K092915 — CEDARA WEBACCESS, MODEL: 2.4Cedara Software Corp.·cleared 2010-06-23

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

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

Reason for recall

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

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