GE Healthcare — Class II medical device recall Z-1164-2013
Terminated recall by GE Healthcare, LLC, reported 2013-05-01, distributed in GA, NY. GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processin
| Recall number | Z-1164-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-10-06 |
| Classified | 2013-04-23 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-02-04 |
| Distributed | GA, NY |
| Countries outside the US | CA, CH, IL, IT |
| Quantity | 11 |
| Reason classes | software |
| Serial numbers | 00000000211423001, 00000CZC827NRN000, 00000CZC8283V4000, 0000CZC7105FJM000, 0000CZC8161XJT000, 0000CZC8283TX5001, 0000CZC8283V47000, 0000CZC8283V72001, 0000CZC83942HL000, 0000CZC8396CC9001, 0000CZC94154WV003 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.