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

Recall Z-2403-2020 — Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including

U.S. FDA — Device Enforcement · United States · 2020-05-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2403-2020
Date of alert
2020-05-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00842000100041
Reported risk: An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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