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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medial technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medial images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Recall Number Z-2238-2012
Classification Class II
Code Info Horizon Medial Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
Product Distributed Qty 516 units
Reason For Recall There is a potential to save reports in RadReport with an Incorrect Final Status.

Event Detail

Event Id 62567
Product Type Devices
Status Ongoing
Recalling Firm Mckesson Medical Imaging Group
City Richmond
State BC
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.