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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 Recall
McKesson Horizon Medical Imaging
see related information
Date Posted September 30, 2013
Recall Status1 Open
Recall Number Z-2318-2013
Recall Event ID 66301
Premarket Notification
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, Georgia 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 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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