Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures
Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical 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 2/5 (Moderate).
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. The hazard involves potential system failure that could interrupt clinical treatment, but the source text does not report any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 4,095 units of the AXIOM Sensis diagnostic computer. The device is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and intracardiac electrophysiology studies. The recall covers units with specific model numbers and serial numbers distributed nationwide.
The recall is due to a risk that an extremely dusty computer can cause problems at system start or, rarely, cause a system failure. If the Sensis system fails, its functions cannot be used. This failure may require clinical treatment to be terminated, restarted, or transferred to a functioning system.
Healthcare facilities should perform a system check prior to performing exams. Users should identify affected units by checking the model and serial numbers listed in the official recall notice.
The recalled product
- Product
- AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 4,095
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 (5)
- Model no.: 10764561
- 11007641
- 6623974
- 6634633
- 6634641
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 · system failure
See all →- HighDxI 9000 Access Immunoassay Analyzer calibration system error recall
FDA (Devices) · 2025-07-02
- HighXhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring
FDA (Devices) · 2025-01-15
- HighBD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall
FDA (Devices) · 2024-06-05
- HighPhilips Allura Xper X-ray systems disk bay component may malfunction
FDA (Devices) · 2024-02-28
- HighMedfusion Syringe Pumps Recalled for Force Sensor Calibration Drift
FDA (Devices) · 2023-10-18
Similar recalls
- HighSiemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation
FDA (Devices) · 2022-06-15
- HighFDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
FDA (Devices) · 2022-01-26
- HighSensis Vibe Cardiac Imaging System Software May Crash During Documentation
FDA (Devices) · 2024-07-31
- ModerateSensis Signal Input Box recall for patient electrical leakage hazard with improper mounting
FDA (Devices) · 2022-08-24
- ModerateSiemens AXIOM Artis Angiography Systems Recalled for Cooling System Contamination
FDA (Devices) · 2016-08-17
- HighSensis Vibe Hemo Medical Device Software May Crash
FDA (Devices) · 2024-01-17