Reported May 1, 2013 · Terminated
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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
- Lot codes and dates
- Mfg Lot or Serial #
0000CZC7105FJM00000000CZC827NRN00000000CZC8283V40000000CZC8283V470000000CZC8283V720010000CZC8283TX5001000000002114230010000CZC8161XJT0000000CZC94154WV0030000CZC83942HL0000000CZC8396CC9001
- Mfg Lot or Serial #
- Amount recalled
- 11
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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