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Recall Observatory FDA recall evidence

Device product

McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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-1617-2014

April 17, 2014

Class II

Product summary

Firm
Mckesson Medical Immaging
Event
Event 68208
Status
Terminated
Classification
Class II
Quantity
45
Official record key
device-enforcement:Z-1617-2014

Official wording

Reason: High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.

Code information: Model MR 12.0

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, and the countries of Canada and France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.