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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
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/
Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta, Georgia 30005
For Additional Information Contact Paul Sumner
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