Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues
Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.
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 high-risk medical device (linear accelerator) with a software defect addressing safety issues, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 103 units of the ARTISTE family of linear accelerator systems. These medical devices are used to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The recall is being conducted to install a software patch that addresses several safety issues.
The affected units are distributed nationwide. The recall covers specific model numbers 08162815 and 8168754, along with a list of specific serial numbers provided in the agency's documentation. The source text does not specify the exact nature of the safety issues or report any injuries or illnesses associated with the defect.
Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA, Inc. to arrange for the installation of the required software patch.
The recalled product
- Product
- ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 103
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)
- Model # 08162815
- 8168754 Serial # 10019
- 10626
- 10651
- 10672.10678
- 10702
- 10703
- 10706
- 10712
- 10758
- 10767
- 10804
- 10625
- 10063
- 10770
- 10831
- 10008
- 10786
- 10789
- 10756
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens ARTISTE Linear Accelerator Recall for Image Quality Degradation
FDA (Devices) · 2013-06-26
- HighSiemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk
FDA (Devices) · 2015-09-30
- HighSiemens Linear Accelerators Recalled for Potential Radiation Dosing Error
FDA (Devices) · 2012-08-01
- SevereSiemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk
FDA (Devices) · 2013-12-11
- HighSiemens Linear Accelerators Recalled for Potential Patient Collision Risk
FDA (Devices) · 2014-08-20
- HighSiemens ARTISTE MV System Linear Accelerator Recalled for Software Issue
FDA (Devices) · 2015-03-25