Siemens Medical Solutions USA, Inc Recalls

61 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (61)

March 12, 2026
ARTIS Pheno VE30A and VE40A, Model 10849000
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Class II
March 10, 2026
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Class II
December 29, 2025
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II
December 29, 2025
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II
December 19, 2025
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
December 19, 2025
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
December 19, 2025
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
December 19, 2025
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
December 5, 2025
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Class II
October 24, 2025
MAMMOMAT Revelation;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
October 24, 2025
MAMMOMAT Inspiration;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
October 24, 2025
MAMMOMAT Fusion;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
October 1, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Lumina (DE). Model Number: 11344916.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Prisma. Model Number: 10849582.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
BIOGRAPH One (DE). Model Number: 11689172.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
Biograph mMR. Model Number: 10433372.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Verio. Model Number: 10276755.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Verio Dot. Model Number: 10684333.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Vida Fit. Model Number: 11410481.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 28, 2025
MAGNETOM Connectom.X. Model Number: 11371480.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
August 12, 2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Limited system movements after startup .
Class II
June 4, 2025
UROSKOP Omnia. Model Number: 10094910
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Class II
June 4, 2025
UROSKOP Omnia Max. Model Number: 10762473
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Class II
May 15, 2025
ARTIS 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. Proc
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
May 15, 2025
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
May 15, 2025
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
May 15, 2025
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
January 2, 2025
ARTIS One Angiographic X-Ray System
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Class II
August 15, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II
August 15, 2024
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II
August 15, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II
July 3, 2024
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizati
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II
July 3, 2024
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as wel
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II
July 3, 2024
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or e
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II
July 3, 2024
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic cathet
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II
July 2, 2024
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II
July 2, 2024
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II
July 2, 2024
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II
July 2, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II
May 31, 2024
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 47552
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Materi
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
May 31, 2024
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
March 21, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis z
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Class II
February 23, 2024
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB1
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Class II
February 23, 2024
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Class II
February 23, 2024
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Class II
November 29, 2023
Sensis Vibe Hemo
The possibility of the Sensis documentation functionality application to crash.
Class II

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