Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories
Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.
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 used for cancer treatment where the use of unvalidated accessories poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling nine Siemens Linear Accelerator (LINAC) units. These devices are used to deliver X-ray radiation for the therapeutic treatment of cancer.
The recall was initiated because Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories that have not been validated as being compatible with Siemens LINAC models. The affected units are distributed in the states of Alabama, Maine, Pennsylvania, Illinois, and California.
Customers should contact Siemens Medical Solutions USA, Inc. to determine if their equipment is affected and to receive instructions regarding the use of compatible accessories.
The recalled product
- Product
- Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 9
Distribution
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
Similar recalls
- SevereSiemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk
FDA (Devices) · 2013-12-11
- SevereSiemens Oncor Linear Accelerators Recalled for Dark Current Radiation Risk
FDA (Devices) · 2013-12-11
- HighSiemens ARTISTE Linear Accelerators Recalled for Software Safety Issues
FDA (Devices) · 2016-10-05
- HighSiemens PRIMUS Linear Accelerators Recalled for Software Safety Issues
FDA (Devices) · 2016-10-05
- HighSiemens Linear Accelerators Recalled for Potential Patient Collision Risk
FDA (Devices) · 2014-08-20
- HighSiemens Oncor Expression Linear Accelerator Software Update Recall
FDA (Devices) · 2018-04-25