Siemens Artis zee Ceiling X-Ray System Recall for Loose Screws
Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect 'can result in severe injuries to patients and operating personnel,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or risk of severe harm, warranting a score of 4 (Severe).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 276 units of the Siemens Artis zee ceiling-mounted Interventional Fluoroscopic X-Ray System (Model Number: 10094137). The recall also applies to Artis Q, Artis Pheno, or Artis Icono systems equipped with a DCS Extended or DCS Movable.
The recall was issued because individual screws in the connection joining the pivot bearing to the ceiling-mounted support may work loose or snap off. This defect can result in severe injuries to patients and operating personnel. The affected units were distributed nationwide.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for addressing the defect.
The recalled product
- Product
- Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 276
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 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 · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- ModerateSiemens Artis zee X-Ray System Recalled for Cabling Abrasion
FDA (Devices) · 2021-05-05
- SevereSiemens Artis X-Ray Systems Recalled for Patient Table Cracks
FDA (Devices) · 2019-09-04
- HighSiemens Artis zee Ceiling Systems Recalled for Cable Damage Risk
FDA (Devices) · 2014-03-05
- SevereSiemens Artis Biplane Systems Recalled for Ceiling Mount Defect
FDA (Devices) · 2018-02-14
- HighSiemens Artis zee Ceiling Recalled for Display Malfunction
FDA (Devices) · 2018-07-04
- ModerateSiemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues
FDA (Devices) · 2018-11-21