GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk
GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but the potential for misdiagnosis poses a significant safety risk, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 11 units of the Xeleris 2 Processing & Review Workstation. These devices are used for the display, processing, archiving, and communication of data acquired by Emission Tomography cameras in diagnostic radiology, including SPECT and planar imaging.
The recall is due to a software issue in the Xeleris 2.1 workstation used for processing Discovery 530/570 data. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation-corrected images. This issue may lead to a potential for misdiagnosis.
The affected units were distributed worldwide, including in the United States (specifically Georgia and New York), Canada, Israel, Italy, and Switzerland. Users should contact GE Healthcare for further instructions regarding the software issue.
The recalled product
- 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)…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 11
Distribution
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