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

Recall Z-0137-2017 — CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

U.S. FDA — Device Enforcement · United States · 2016-01-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0137-2017
Date of alert
2016-01-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Reported risk: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
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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