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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 64787
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare It
City Barrington
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide Distribution in the state of OK

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Software Version: 5.0 Class II 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 (Current, Prior or Baseline), with a border color, and with Study Date anotation. The newest study is labeled "Current", the next newest study is labeled "Prior", and if there are 3 or more studies open the oldest study is labeled "Baseline". When viewing multiple studies simultaneously, the border color and "Current"/"Prior"/"Baseline" labeling may be incorrect. 1 unit Z-0034-2014