FDA Device recall Z-1164-2013
GE Healthcare, Xeleris 2 Processing & Review Workstation
- FDA Device
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of GE Healthcare, Xeleris 2 Processing & Review Workstation by Ge Healthcare, citing 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 importe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1164-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-06 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | GA, NY |
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.
Identifiers
| code_info | Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 000…Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2013%22
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