Siemens Artis zee X-ray System Recalled for Component Defect
Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.
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, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific Artis zee angiographic x-ray systems. The recall involves systems equipped with an A100 Plus generator from a specific delivery lot and a 2-focus Megalix Cat Plus tube unit.
The recall is due to a component defect that can result in system failures. The source text does not specify the nature of the failures or any reported injuries or illnesses.
A total of 97 units were distributed worldwide, with 12 distributed in the United States. Affected units are located in Arkansas, Kansas, Michigan, Iowa, Illinois, Wisconsin, Minnesota, West Virginia, Ohio, and New York. Users should contact Siemens Medical Solutions USA, Inc. for further instructions.
The recalled product
- Product
- Artis zee,x-ray system, angiographic Artis zee is a family of 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 with the…
- Manufacturer
- Siemens Medical Solutions USA, Inc
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
Same hazard · component defect
See all →- ModerateMedline EBSI dressing change kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline femoral block trays contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline breast hernia port kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateCenturion dialysis and dressing change kits contain recalled Mastisol adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline EBSI kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
Similar recalls
- ModerateSiemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects
FDA (Devices) · 2017-01-18
- HighSiemens Artis zeego X-ray Systems Recalled for Mechanical and Electrical Defects
FDA (Devices) · 2016-04-06
- HighSiemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects
FDA (Devices) · 2017-01-18
- HighSiemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect
FDA (Devices) · 2016-11-23
- ModerateSiemens Artis zee Angiographic X-ray System Software Recall
FDA (Devices) · 2017-04-26
- ModerateSiemens Artis zee/zeego Systems Recalled for X-Ray Tube Focal Spot Failure
FDA (Devices) · 2015-01-21