FDA-Device2017-03-29Class II
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
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.
Sold states
US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
Affected count
17 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1415-2017Don't want to check this manually?
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