GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-1164-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 6, 2011

Date Posted: May 1, 2013

Recall Number: Z-1164-2013

Event ID: 64804

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.

Status: Terminated

Product Quantity: 11

Code Information:

Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001

Distribution Pattern:

Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated