Recall Z-0878-2017— Merge Healthcare, Inc.

Name: FDA recall Z-0878-2017
Creator: U.S. Food and Drug Administration
Published: 2015-10-08

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-10-08, terminated 2018-06-22. It names one FDA 510(k) clearance: K022881. Product: Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-08
Terminated: 2018-06-22
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K022881 — CEDARA I-SOFTVIEWCedara Software Corp.·cleared 2002-10-22

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

Reason for recall

Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

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