Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1496-2017 — Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

U.S. FDA — Device Enforcement · United States · 2015-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1496-2017
Date of alert
2015-09-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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