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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical Imaging

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 Class 2 Recall
Horizon Medical Imaging
see related information
Date Posted June 06, 2014
Recall Status1 Open
Recall Number Z-1728-2014
Recall Event ID 68431
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Horizon Medical Imaging 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 HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; 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 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0
Recalling Firm/
Manufacturer
Mckesson Medical Immaging
Suite 130-10711 Cambie Road
Richmond, British Columbia
For Additional Information Contact Paul Summer
404-338-3556
Manufacturer Reason
for Recall
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
FDA Determined
Cause 2
DESIGN: Software Design
Action McKesson sent an Urgent Field Safety Notice dated May 20, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were informed that the potentially affected software versions will be corrected without removing the systems from their location. Customers were instructed to distribute the notice to all those within their organization who need to be aware and alert all those affilliated with their organization that are affected by this field safety notice. All customers receiving the Field Safety Notice should contact McKesson Support as soon as possible at 1-800-663-2533 to arrange installation of the software update. Customers with questions should contact the Customer Support Department and ask to speak to their Support Manager.
Quantity in Commerce 659
Distribution Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
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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