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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS)

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 Class 2 Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS)see related information
Date Initiated by FirmJuly 12, 2016
Date PostedSeptember 22, 2016
Recall Status1 Terminated 3 on November 20, 2019
Recall NumberZ-2872-2016
Recall Event ID 75194
510(K)NumberK043146 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMcKesson 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.
Code Information McKesson Radiology versions 12.1.1 and 12.2
FEI Number 3003757840
Recalling Firm/
Manufacturer		 Mckesson Medical Imaging Group
10711 Cambie Rdsuite 130
Richmond Canada British Columbia
For Additional Information ContactPaul Sumner
404-338-3556
Manufacturer Reason
for Recall		The STAT priority icon was not displayed in the Study List when the study was opened.
FDA Determined
Cause 2		Software design
ActionMcKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.
Quantity in Commerce164 devices
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LLZ
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