Siemens CT Scanners: Software Errors May Interrupt Scanning Workflows
Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.
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: This is an FDA Class II medical device recall affecting operational function with potential for diagnostic delay. While no patient injuries or illnesses have been reported, the identified software errors create actual risk of harm through delayed or aborted scans requiring patient rescans.
Plain-English summary
Siemens Medical Solutions has recalled 31 CT scanning systems with specific software versions due to sporadic software errors. The affected systems include SOMATOM go.Up, go.All, go.Top, and X.cite models.
The software errors in versions syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3, and VA30A_FP2 may cause unexpected notifications, scanning workflow interruptions, and diagnostic delays. In some cases, scans may abort, requiring patient rescans.
Siemens is distributing remote and onsite software updates to correct the problem. Affected facilities should contact Siemens Medical Solutions USA, Inc. to install the appropriate software update for their system model and current software version.
The recalled product
- Product
- Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 31
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 (20)
- US Serial Numbers: 111307
- 111526
- 119328
- 108158
- 123104
- 111219
- 123054
- 117633
- 111566
- 111427
- 123059
- 117558
- 117533
- 119317
- 117647
- 108088
- 123060
- 123118
- 123055
- 111518
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 defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSiemens SOMATOM CT Software Recall for Workflow Interruptions
FDA (Devices) · 2021-03-24
- HighCT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation
FDA (Devices) · 2022-04-27
- ModerateSiemens SOMATOM go.Up CT Systems Recalled for Performance Issues
FDA (Devices) · 2019-07-10
- ModerateSiemens CT System Recalled for Potential Scanning Workflow Interruptions
FDA (Devices) · 2019-07-10
- ModerateSiemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions
FDA (Devices) · 2019-07-10
- ModerateSiemens SOMATOM go.Up CT Scanner Recalled for Performance Issues
FDA (Devices) · 2019-07-10