Recall Z-1164-2013— GE Healthcare, LLC

Name: FDA recall Z-1164-2013
Creator: U.S. Food and Drug Administration
Published: 2011-10-06

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-10-06, terminated 2014-02-04. It names one FDA 510(k) clearance: K051673. 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. 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: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-10-06
Terminated: 2014-02-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K051673 — XELERIS 2 PROCESSING AND REVIEW WORKSTATIONGE Medical Systems·cleared 2005-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.