Siemens Artis zee Systems Recalled for Potential Liquid Seepage
Siemens Medical Solutions is recalling Artis zee angiography systems because liquid may seep through the table cover, potentially preventing table movement.
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 risk-of-harm product (medical device) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Siemens Artis zee systems, which are dedicated angiography systems used for diagnostic imaging and interventional procedures. The recall is due to a defect where a large amount of liquid may seep through the top cover of the table and penetrate the internal components.
If this liquid seepage occurs, the table movements may no longer be possible. The source text explicitly states that no injuries have been reported in connection with this issue.
The recall covers units distributed nationwide in the US. Affected units are identified by specific model numbers and serial numbers listed in the official recall documentation. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the defect.
The recalled product
- Product
- Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro…
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 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 · liquid seepage
See all →- HighSiemens Axiom Artis Angiography Systems Recalled for Liquid Seepage Risk
FDA (Devices) · 2015-08-12
Similar recalls
- HighSiemens Artis Angiography Systems Recalled for Software Movement Blockage
FDA (Devices) · 2020-03-25
- HighSiemens Medical Solutions Recalls AXIOM Artis zee and Q Angiography Systems
FDA (Devices) · 2017-09-06
- HighSiemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak
FDA (Devices) · 2016-04-06
- ModerateSiemens Artis zee/zeego X-Ray Systems Recalled for Cooling System Leak
FDA (Devices) · 2016-04-06
- HighSiemens Artis Q Angiography Systems Recalled for Software Movement Issue
FDA (Devices) · 2020-03-25
- HighSiemens Artis zee/zeego Systems Recalled for Position Sensor Fault
FDA (Devices) · 2015-07-01