Manufacturer

Siemens Medical Solutions USA, Inc

162 recalls in our database name Siemens Medical Solutions USA, Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 162

HighFDA (Devices)·Z-1311-2023·2023-04-05
Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk
Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.
Product
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2023·2023-03-01
Luminos Agile Diagnostic Imaging System Collision Risk Recall
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
Product
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1165-2023·2023-03-01
Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
Product
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2023·2023-03-01
Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.
Product
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2023·2023-03-01
Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk
Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.
Product
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1168-2023·2023-03-01
Diagnostic imaging system recalled due to ceiling and wall collision risk
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
Product
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2023·2023-02-08
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.
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 108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2023·2023-02-01
Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems
Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.
Product
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2023·2023-01-25
X-ray imaging system footrests may detach from patient tables
Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.
Product
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1000-2023·2023-01-25
Medical X-ray equipment patient table footrests recalled due to detachment risk
Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.
Product
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1001-2023·2023-01-25
Patient table footrest may detach from AXIOM Luminos Agile
Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.
Product
AXIOM Luminos Agile
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0956-2023·2023-01-25
ARTIS medical imaging systems recalled for mechanical connection failure
Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.
Product
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2023·2023-01-11
Programmable Diagnostic Computer Software Update Addresses Crash Errors
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
Product
Programmable Diagnostic Computer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2023·2022-12-21
Linear accelerator software addresses potential wrong-site treatment risk
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
Product
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0119-2023·2022-11-02
ARTIS pheno interventional x-ray system software defect prevents treatment continuation
Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.
Product
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1647-2022·2022-09-07
Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure
Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.
Product
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1645-2022·2022-09-07
X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
Product
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2022·2022-09-07
X-ray imaging system hardware defect may prevent operation
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
Product
Artis pheno- Model No. 10849000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1558-2022·2022-08-24
Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting
Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.
Product
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2022·2022-07-27
Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2022·2022-07-27
Sensis Vibe Combo Device Recalled for Software Communication Failure
The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.
Product
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2022·2022-07-13
Imaging system software displays mirrored CT images during data loading
Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.
Product
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2022·2022-07-13
Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use
Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.
Product
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1342-2022·2022-07-13
Siemens X-ray System Fan Wear May Cause Equipment Malfunction
Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-1294-2022·2022-07-06
Artis Pheno fluoroscopic system may lose video display signals
Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.
Product
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Category
Medical Device
Distribution
Distributed nationwide