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Recall Observatory FDA recall evidence

Device product

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

Z-0137-2017

January 30, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75239
Status
Terminated
Classification
Class II
Quantity
844 sites potentially have the affected versions
Official record key
device-enforcement:Z-0137-2017

Official wording

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.

Code information: Versions prior to 5.2.9

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.