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Recall Observatory FDA recall evidence

Device product

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

Z-1415-2017

April 04, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76401
Status
Terminated
Classification
Class II
Quantity
17 sites potentially have the affected versions
Official record key
device-enforcement:Z-1415-2017

Official wording

Reason: A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

Code information: Version 9.0.9 and earlier using EchoIMS.

Distribution pattern: US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.