Company:GE Healthcare
Date of Enforcement Report 5/1/2013
Class ll:
PRODUCT
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration Recall Number Z-1164-2013
REASON
GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 10/6/2012. Voluntary: Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
11
DISTRIBUTION
Nationwide and Internationally
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