medical Class II Updated 2017-03-29

Merge Healthcare, Inc. recalls Merge Cardio software with Issuer of Patient ID (IPID). The

Recalled Product

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Hazard / Issue

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.

Issued by

FDA

Affected States: GA, IL, MD, MI, MO, OH, TN, VT
Lot/Code Info: Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)
View official government recall

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