PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 26, 2016 Initiated: January 30, 2016 #Z-0137-2017

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.

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
844 sites potentially have the affected versions
Distribution
Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
Location
Hartland, WI

Frequently Asked Questions

What product was recalled?
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 844 sites potentially have the affected versions.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0137-2017.