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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Horizon Medical Imaging

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  Class 2 Device Recall McKesson Horizon Medical Imaging see related information
Date Initiated by Firm September 04, 2013
Date Posted September 30, 2013
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-2318-2013
Recall Event ID 66301
510(K)Number K043146  
Product Classification System, image processing, radiological - Product Code LLZ
Product McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
Code Information Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.
Recalling Firm/
Manufacturer		 Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta GA 30005
For Additional Information Contact Paul Sumner
404-338-2376
Manufacturer Reason
for Recall		 Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
FDA Determined
Cause 2		 Software change control
Action Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.
Quantity in Commerce 329 units
Distribution Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada 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
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