Recall Z-0137-2017— Merge Healthcare, Inc.

Name: FDA recall Z-0137-2017
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 2020-10-05. It names one FDA 510(k) clearance: K092954. Product: CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Terminated: 2020-10-05
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K092954 — CADSTREAM VERSION 5Confirma, Inc.·cleared 2009-11-06

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

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

Reason for recall

The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

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