FDA-Device2014-08-06Class II

Horizon Medical Imaging It 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 imaging systems.

Mckesson Medical Immaging
Hazard

The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

Sold states
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
Affected count
659 units
Manufactured in
Suite 130-10711 Cambie Road, Richmond, British Columbia, Canada
Products
Horizon Medical Imaging It 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 imaging systems.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2121-2014

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