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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS).

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 Class 2 Recall
Horizon Medical Imaging, Picture Archive Communication System (PACS).
see related information
Date Posted February 12, 2014
Recall Status1 Open
Recall Number Z-0976-2014
Recall Event ID 67374
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Horizon Medical Imaging, Picture Archive Communication System (PACS).
Code Information HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.
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
Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
FDA Determined
Cause 2
DESIGN: Software Design
Action McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
Quantity in Commerce 618 units
Distribution U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
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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