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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Radiology

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 Class 2 Recall
McKesson Radiology
see related information
Date Posted December 20, 2013
Recall Status1 Terminated on June 03, 2014
Recall Number Z-0556-2014
Recall Event ID 67014
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Code Information MR 12.0
Recalling Firm/
Manufacturer
Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta, Georgia 30005
For Additional Information Contact Paul Sumner
404-338-3556
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
OTHER/UNDETERMINED: Pending
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 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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