Class 2 Device Recall McKesson Radiology 12.2 Picture Archive Communication System (PACS)

• Date Initiated by Firm: December 02, 2016
• Create Date: March 02, 2017
• Recall Status: Terminated on November 24, 2017
• Recall Number: Z-1396-2017
• Recall Event ID: 76500
• 510(K)Number: K140909
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
• Code Information: Model 12.2
• FEI Number: 3003757840
• Recalling Firm/ Manufacturer: Mckesson Medical Imaging; 10711 Cambie Rd Suite 130; Richmond Canada
• For Additional Information Contact: Paul Sumner; 404-338-3556
• Manufacturer Reason for Recall: Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.
• FDA Determined Cause: Software design
• Action: McKesson sent an Urgent Field Safety Notice on December 2, 2016 to customers with potentially affected software versions. The notice indicated that they were to contact McKesson to install a software update to correct the issue, and that they read and understood the Field Safety Notice.
• Quantity in Commerce: 17
• Distribution: AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = LLZ