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

Recall Z-2062-2019 — Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

U.S. FDA — Device Enforcement · United States · 2019-07-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2062-2019
Date of alert
2019-07-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00842000100690
Reported risk: Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
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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