Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.
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 recall affecting a medical imaging system where potential for treatment disruption represents a risk-of-harm scenario. No injuries or hospitalizations have been reported; the hazard is operational in nature and occurs only in rare cases.
Plain-English summary
Siemens Medical Solutions USA is recalling multiple models of fluoroscopic X-ray systems (Artis zee and Artis Q series) used in clinical settings. The recall affects 609 units in the United States and 1627 units worldwide, identified by specific serial numbers for each model variant.
In rare cases, these systems may only boot into backup mode after an abrupt shutdown and fail to reach full operating mode. This limitation could force healthcare facilities to cancel ongoing clinical treatments or transition patients to alternative imaging systems.
Healthcare facilities operating these specific models should review the affected serial numbers and contact Siemens Medical Solutions USA for further instructions and remediation options.
The recalled product
- Product
- System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor…
- Manufacturer
- Siemens Medical Solutions USA, Inc
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 · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighFluoroscopic X-Ray System Stand Movement May Be Blocked During Use
FDA (Devices) · 2022-07-13
- SevereSiemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure
FDA (Devices) · 2019-07-10
- SevereSiemens Artis X-Ray Systems Recalled for Potential Screw Failure
FDA (Devices) · 2019-07-10
- SevereSiemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk
FDA (Devices) · 2019-07-10
- SevereSiemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure
FDA (Devices) · 2019-07-10
- HighSiemens Artis X-ray systems cooling malfunction may halt procedures
FDA (Devices) · 2024-04-24