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). |
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| 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. |
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