Medical device recalls Moderate risk

Mckesson Medical Immaging recalls McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 1…

Recall date
February 18, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1182-2016
FDA classification
Class II
Brand / firm
Mckesson Medical Immaging
Sold / distributed
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Gr…

Why it was recalled

McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

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