FDA-Device2017-03-29Class II
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.
Sold states
US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.
Affected count
16 sites were originally identified as potentially having the affected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1496-2017Don't want to check this manually?
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