Recall Z-1164-2013 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
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
| Date | Apr 23, 2013 (initiated Oct 6, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated October 5, 2011, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to contact their local GE Healthcare Service Representative if they have questions or concerns. They may also contact GE Healthcare Call Center , United States or Canada at 800-437-1171. Other countries 262-896-2890. For questions regarding this recall call 262-513-4122. |
| Quantity | 11 |
| Distribution | Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE Medical Systems, Jul 18, 2005 |