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
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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
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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