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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Cardio Imaging

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 Class 2 Recall
Centricity Cardio Imaging
see related information
Date Posted October 21, 2013
Recall Status1 Open
Recall Number Z-0034-2014
Recall Event ID 64787
Premarket Notification
510(K) Number
K112570 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
Code Information Software Version: 5.0
Recalling Firm/
Manufacturer
GE Healthcare It
540 W Northwest Hwy
Barrington, Illinois 60010-3051
Manufacturer Reason
for Recall
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future. Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171.
Quantity in Commerce 1 unit
Distribution USA Nationwide Distribution in the state of OK
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 = GE HEALTHCARE INTEGRATED IT SOLUTIONS
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