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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical Imaging Systems

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 Class 2 Recall
Horizon Medical Imaging Systems
see related information
Date Posted May 28, 2010
Recall Status1 Terminated on August 15, 2012
Recall Number Z-1735-2010
Recall Event ID 55723
Premarket Notification
510(K) Number
K043146 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. 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 (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613. On June 29, 2010 the recall was amended to include: All installations of Horizon Medical imaging (HMI) 11.0.6, 11.0.8 and 11.5.1
Recalling Firm/
Manufacturer
Mckesson Medical Immaging
Suite 130-10711 Cambie Road
Richmond, British Columbia
For Additional Information Contact Laurie English
404-338-2376
Manufacturer Reason
for Recall
Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.
FDA Determined
Cause 2
DESIGN: Software Design
Action McKesson Medical Imaging Company issued an "Advisory Notice" dated May 7, 2010. Consignees were notified of the affected product and advised to contact McKesson Customer Support department to review their sites current configuration and install the appropriate product software update(s). For further information, contact McKesson Medical Imaging Customer Support at 1-800-663-2533. On June 19, 2010 the recall was amended to include the following actions to follow: Instead of highlighting the anchor study in the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsing through other documents. A software update that prevents the problem from occurring is currently under development for all affected releases and will be available in approximately three months. Consignees will be notified when the software update is ready to be installed on their system.
Quantity in Commerce 100 units
Distribution Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada
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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