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Recall Observatory FDA recall evidence

Device product

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Z-1091-2017

March 28, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76214
Status
Terminated
Classification
Class II
Quantity
242 sites potentially have the affected versions
Official record key
device-enforcement:Z-1091-2017

Official wording

Reason: There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Code information: Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.