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U.S. Department of Health and Human Services

Class 2 Device Recall Picture Archive Communication System (PACS)

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 Class 2 Recall
Picture Archive Communication System (PACS)
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1617-2014
Recall Event ID 68208
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
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.
Code Information Model MR 12.0
Recalling Firm/
Manufacturer
Mckesson Medical Immaging
Suite 130-10711 Cambie Road
Richmond, British Columbia
For Additional Information Contact Paul Sumner
404-338-3556
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design Change
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.
Quantity in Commerce 45
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY
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