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/ Manufacturer |
Mckesson Information Solutions LLC 5995 Winward Plaza Information Technology Business Alpharetta GA 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 |
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY
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