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Recall Observatory FDA recall evidence

Device product

McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). 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.

Z-2872-2016

July 12, 2016

Class II

Product summary

Firm
Mckesson Medical Imaging Group
Event
Event 75194
Status
Terminated
Classification
Class II
Quantity
164 devices
Official record key
device-enforcement:Z-2872-2016

Official wording

Reason: The STAT priority icon was not displayed in the Study List when the study was opened.

Code information: McKesson Radiology versions 12.1.1 and 12.2

Distribution pattern: Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The STAT priority icon was not displayed in the Study List when the study was opened.