FDA-Device2013-05-01Class II
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
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
Affected count
11
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2013Don't want to check this manually?
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