Siemens LANTIS System Recall for Unvalidated Operating System Risks
Siemens is recalling 108 LANTIS linear accelerator systems because using the software with unvalidated operating systems can cause data corruption and incorrect treatment records.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves data integrity and software compatibility rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 108 LANTIS linear accelerator systems, including LANTIS Commander, LANTIS 6.1 Commander, and LANTIS 8.3 Commander units. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers units with material numbers 4503178, 5493072, and 8148178, distributed nationwide.
The recall is due to a potential risk when using LANTIS OIS System client software with operating systems that have not been validated and released by the manufacturer. This incompatibility can result in incorrectly stored data, such as treatment records, and corruption of the LANTIS database.
Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software compatibility issue and ensure data integrity.
The recalled product
- Product
- Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 108
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)
- Material nos.: 4503178
- 5493072
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · data corruption
See all →- HighSynchroMed II Infusion Pump Recalled Due to Memory Data Corruption
FDA (Devices) · 2024-10-30
- HighPhilips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption
FDA (Devices) · 2020-06-17
- HighElekta Recalls Leksell GammaPlan Software Due to Memory Corruption
FDA (Devices) · 2015-06-17
- HighBaxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk
FDA (Devices) · 2013-12-25