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Class 2 Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS) |
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Date Initiated by Firm |
July 12, 2016 |
Date Posted |
September 22, 2016 |
Recall Status1 |
Terminated 3 on November 20, 2019 |
Recall Number |
Z-2872-2016 |
Recall Event ID |
75194 |
510(K)Number |
K043146
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Product Classification |
System, image processing, radiological - Product Code LLZ
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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. |
Code Information |
McKesson Radiology versions 12.1.1 and 12.2 |
Recalling Firm/ Manufacturer |
Mckesson Medical Imaging Group 10711 Cambie Rdsuite 130 Richmond Canada British Columbia
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For Additional Information Contact |
Paul Sumner 404-338-3556
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Manufacturer Reason for Recall |
The STAT priority icon was not displayed in the Study List when the study was opened.
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FDA Determined Cause 2 |
Software design |
Action |
McKesson 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 Commerce |
164 devices |
Distribution |
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 |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY
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