Z-1164-2013Class II

GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and...

Name: Z-1164-2013 GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and...
Creator: GE Healthcare, LLC
Published: 2011-10-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-10-06 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras... on 2011-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1164-2013
Classification: Class II
Status: Terminated
Initiated: 2011-10-06
Posted: 2013-04-23
Terminated: 2014-02-04
Recalling firm: GE Healthcare
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
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 in commerce: 11
Distribution: Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
Product codes and lots: Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1164-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1164-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-23

Product code LLZ

K051673Class IIXeleris 2 Processing and Review WorkstationGE Medical Systems / cleared 2005-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)