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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical

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 Class 2 Recall
Horizon Medical
see related information
Date Posted August 18, 2011
Recall Status1 Terminated on October 04, 2012
Recall Number Z-3035-2011
Recall Event ID 59365
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Code Information Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8
Recalling Firm/
Manufacturer
Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta, Georgia 30005
For Additional Information Contact Laurie English
404-338-2376
Manufacturer Reason
for Recall
Images for one patient may appear in the study of another patient.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.
Quantity in Commerce 438 devices
Distribution Worldwide Distribution--USA (nationwide) Australia, Canada, Guam 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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