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Fusion Workstation.; Indicated for the transmission and review of radiological images.

FDA Recall #Z-0294-2017 — Class II — October 28, 2011

Recall #Z-0294-2017 Date: October 28, 2011 Classification: Class II Status: Terminated

Product Description

Fusion Workstation.; Indicated for the transmission and review of radiological images.

Reason for Recall

After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

Recalling Firm

Merge Healthcare, Inc. — Hartland, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

13 sites potentially hae the affected version

Distribution

Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.

Code Information

Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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