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Recall Observatory FDA recall evidence

Device product

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

Z-1403-2017

April 04, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76590
Status
Terminated
Classification
Class II
Quantity
110 sites potentially have the affected versions
Official record key
device-enforcement:Z-1403-2017

Official wording

Reason: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

Code information: Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.

Distribution pattern: Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.