Siemens Biograph Horizon PET/CT Scanner Software Recall for Image Errors
Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.
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 medical device with a defect that affects diagnostic image accuracy, posing a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 42 units of the Biograph Horizon PET/CT scanner equipped with PETsyngo VJ20A software. The recall covers units distributed worldwide, including the United States, Australia, France, India, Japan, and the Netherlands.
The recall is due to an error in the VJ20A software where array values are indexed improperly when the norm file is created during quality control. This causes incorrect values to be applied during data reconstruction, which can lead to a gradient in the PET images. The severity of the error depends on the positioning of the PET QC phantom relative to the center of the field of view.
Healthcare facilities using these scanners should contact Siemens Medical Solutions for further instructions on how to address the software error.
The recalled product
- Product
- Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software version VJ20A. Code No. 10532746
- 10532748.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- HighSiemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue
FDA (Devices) · 2018-05-30
- ModerateSiemens Biograph Horizon PET/CT System Recalled for Design Defects
FDA (Devices) · 2019-01-16
- ModerateSiemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph 40 PET/CT Scanners Recalled for Calibration Error Risk
FDA (Devices) · 2016-06-29