Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/29/2017
Class lI:
PRODUCT
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-1496-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/22/2015. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
11 sites potentially have the affected accessory
DISTRIBUTION
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.
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