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.
FDA Recall Z-1617-2014 · Posted 2014-05-13
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Recalling FirmMckesson Medical Immaging
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-04-17
Date Terminated2016-02-02
Product Quantity45
Reason for Recall
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.
Firm Action
On April 17, 2014, McKesson Medical Imaging Company initiated a process for applying a software solution to all McKesson Radiology customer systems that may be affected to prevent future occurrences of this issue. The systems with the potentially affected software versions will be corrected without removing the systems from their location.
Root Cause
Software Design Change
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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