Company: GE Healthcare It
Date of Enforcement Report: 10/30/2013
Class lI:
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.
Recall Number Z-0034-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 10/2/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Oklahoma
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