GE Healthcare It recalls Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage:

Recalled October 30, 2013 · FDA recall Z-0034-2014 · GE Healthcare It

Hazard

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 Class II

Units

1 unit

Sold at

USA Nationwide Distribution in the state of OK

Description

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.

Manufacturer(s)

GE Healthcare It

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →