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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Radiology

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  Class 2 Device Recall McKesson Radiology see related information
Date Initiated by Firm October 15, 2013
Date Posted December 20, 2013
Recall Status1 Terminated 3 on June 03, 2014
Recall Number Z-0556-2014
Recall Event ID 67014
510(K)Number K043146  
Product Classification Radiological Image Processing System - Product Code LLZ
Product McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Code Information MR 12.0
Recalling Firm/
Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta GA 30005
For Additional Information Contact Paul Sumner
Manufacturer Reason
for Recall
When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.
FDA Determined
Cause 2
Action Consignees were notified via letter (Field Safety Notice) on 10/15/2013.
Quantity in Commerce 6 units
Distribution MO, NY, TN, WV and France.
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 and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY