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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. Image processing system.

Z-2709-2016

February 09, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75027
Status
Terminated
Classification
Class II
Quantity
116 customers potentially have the affected versions
Official record key
device-enforcement:Z-2709-2016

Official wording

Reason: A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

Code information: Versions 10.1 and 10.1.1

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).