Siemens PRIMUS HI Digital Linear Accelerator Software Recall
Siemens is recalling 18 PRIMUS HI Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.
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 addresses a risk-of-harm product (collision during treatment) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 18 units of the PRIMUS HI Digital Linear Accelerator, Model No. 04504200. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer.
The recall is being conducted to update the Control Console software. This update is designed to reduce the risk of collision when delivering automatically sequenced treatments that involve automatic movements of the gantry and/or the treatment table.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Nassau. Specific serial numbers for the 18 affected units are listed in the agency's recall record. Users of these devices should contact Siemens Medical Solutions USA, Inc. for information regarding the software update.
The recalled product
- Product
- PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 18
Distribution
Part of a larger recall action
This product is one of 6 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 6 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 · collision
See all →- SeverePowered Wheelchair Control Software Recall by munevo
FDA (Devices) · 2026-08-12
- Severe
- High
- HighPhilips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard
FDA (Devices) · 2025-04-30
- High
Similar recalls
- HighSiemens PRIMUS Linear Accelerators Recalled for Software Safety Issues
FDA (Devices) · 2016-10-05
- SevereSiemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk
FDA (Devices) · 2020-04-15
- HighSiemens Linear Accelerators Recalled for Potential Patient Collision Risk
FDA (Devices) · 2014-08-20
- HighSiemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory
FDA (Devices) · 2019-05-01
- SevereSiemens PRIMUS HI and Mevatron M2 Linear Accelerators Recalled for Weld Defect
FDA (Devices) · 2017-03-15
- HighSiemens ARTISTE Linear Accelerators Recalled for Software Safety Issues
FDA (Devices) · 2016-10-05