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Recall Observatory FDA recall evidence

Device product

Horizon Medical Imaging 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 imaging systems.

Z-1728-2014

May 29, 2014

Class II

Product summary

Firm
Mckesson Medical Immaging
Event
Event 68431
Status
Terminated
Classification
Class II
Quantity
659
Official record key
device-enforcement:Z-1728-2014

Official wording

Reason: Firm received a complaint that an unreported study performed that day could not be opened from the archive.

Code information: HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0

Distribution pattern: 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, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm received a complaint that an unreported study performed that day could not be opened from the archive.