medical Class II Updated 2017-03-29

Merge Healthcare, Inc. recalls Merge Cardio software using EchoIMS. The firm name on the l

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, FL, IL, MD, MO, OH, OK, TX, VT, WI
Lot/Code Info: Version 9.0.9 and earlier using EchoIMS.
View official government recall

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