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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical Imaging system.

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 Class 2 Device Recall Horizon Medical Imaging system.see related information
Date Initiated by FirmMay 29, 2012
Date PostedAugust 22, 2012
Recall Status1 Terminated 3 on September 12, 2013
Recall NumberZ-2238-2012
Recall Event ID 62567
510(K)NumberK043146 
Product Classification System, image processing, radiological - Product Code LLZ
ProductHorizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Code Information Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
Recalling Firm/
Manufacturer		 Mckesson Medical Imaging Group
10711 Cambie Rdsuite 130
Richmond Canada British Columbia
For Additional Information ContactLaurie English
404-338-3530
Manufacturer Reason
for Recall		There is a potential to save reports in RadReport with an Incorrect Final Status.
FDA Determined
Cause 2		Software design
ActionMcKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.
Quantity in Commerce516 units
DistributionWorldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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