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Mckesson Medical Imaging Group recalls Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management
Recalled August 29, 2012 · FDA recall Z-2238-2012 · Mckesson Medical Imaging Group
Hazard
There is a potential to save reports in RadReport with an Incorrect Final Status. · FDA Class II
Units
516 units
Sold at
Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
Description
There is a potential to save reports in RadReport with an Incorrect Final Status.
Product
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 medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Manufacturer(s)
Mckesson Medical Imaging Group
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →