The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc

156 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.

1–25 of 156

  • HighFDA (Devices)·Z-1814-2026·2026-04-22

    Medical imaging device may deliver unintended radiation exposure during 3D acquisitions

    Siemens ARTIS Pheno imaging systems may expose patients to unintended low-dose radiation during 3D image acquisition due to unregulated radiation dose combined with system rotation. The recall affects 73 units distributed in the U.S. and internationally.

    Product
    ARTIS Pheno VE30A and VE40A, Model 10849000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1653-2026·2026-04-15

    ARTIS Pheno and Icono X-Ray Systems Recalled for Inaccurate Dose Display

    ARTIS pheno and ARTIS Icono X-ray systems may display dramatically higher radiation dose readings than actually applied during patient examinations. The actual dose remains compliant with regulations, though the display error could lead clinicians to question equipment accuracy.

    Product
    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2026·2026-02-11

    CT System Software Recalled for Lack of FDA 510(k) Clearance

    Siemens has recalled NAEOTOM Alpha.Prime CT system software applications that were distributed without FDA 510(k) clearance. Affected systems are located in the US, Canada, Costa Rica, India, and Israel.

    Product
    NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2026·2026-02-11

    Siemens SOMATOM X.ceed CT system software applications recalled for lacking FDA clearance

    Siemens is removing three software applications from SOMATOM X.ceed CT systems worldwide because they lack FDA 510(k) clearance. Affected units are being recalled to ensure regulatory compliance.

    Product
    SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2026·2026-02-11

    NAEOTOM Alpha CT diagnostic software applications recalled for lacking FDA clearance

    Siemens is recalling software applications used in NAEOTOM Alpha CT systems because they lack FDA 510(k) clearance. The recall affects 88 units.

    Product
    NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2026·2026-02-11

    Siemens recalls three software applications from NAEOTOM Alpha.Pro CT systems

    Siemens Medical Solutions is recalling three software applications from NAEOTOM Alpha.Pro CT systems. The applications—syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS—have not received FDA 510(k) clearance.

    Product
    NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2026·2026-02-04

    Siemens LUMINOS fluoroscopic X-ray system automatic flip software error

    A Siemens LUMINOS interventional X-ray system may fail to flip ortho images as intended, risking processing of a previous patient's image. No illnesses or injuries have been reported.

    Product
    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2026·2026-02-04

    X-Ray Imaging System Ortho Images Not Flipped; Possible Display of Previous Patient Images

    A Siemens fluoroscopic X-ray system software issue may prevent ortho images from flipping and could display a previous patient's image. The recall affects 41 units distributed in the US and several other countries.

    Product
    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2026·2026-01-14

    LUMINOS Lotus Max and dRF Max Systems: Collimation Software Error

    Siemens LUMINOS Lotus Max and dRF Max fluoroscopy systems with software version VF11 may display incorrect collimation when rapidly switching between organ programs. The defect affects devices with bucky wall stands for mobile detectors.

    Product
    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0878-2026·2025-12-10

    MAMMOMAT Inspiration operator table recalled for improper bus-installation kit

    Siemens recalls the MAMMOMAT Inspiration operator table due to improper inclusion of a bus-installation kit. The table is designed for stationary operation only and cannot be safely used on buses.

    Product
    MAMMOMAT Inspiration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2026·2025-12-10

    Mammography System Operator Table Sold with Incorrect Bus Installation Kit

    Siemens MAMMOMAT Fusion operator table units were incorrectly sold with a bus-installation kit. The operator table is designed only for stationary operation and is not released for bus transport or installation.

    Product
    MAMMOMAT Fusion;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0431-2026·2025-11-19

    MRI Helium Containment System Rupture Risk from Ice Blockage

    The Siemens MAGNETOM Cima.X Upgrade MRI system's helium venting paths may become blocked by ice, potentially causing helium containment rupture and gas leak into the scanning room.

    Product
    MAGNETOM Cima.X Upgrade. Model Number: 11689304.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2668-2025·2025-10-08

    MRI Scanner Helium Venting System May Leak Due to Ice Blockage

    Siemens MAGNETOM Vida Fit MRI scanners may develop ice blockages in the helium venting system. During a quench event, blocked vents could cause helium pressure buildup and rupture, leading to helium leaks into the scanning room.

    Product
    MAGNETOM Vida Fit. Model Number: 11410481.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2656-2025·2025-10-08

    MAGNETOM Cima.X MRI System Recall for Potential Helium Leak Risk

    Siemens is recalling the MAGNETOM Cima.X MRI system worldwide due to potential ice blockage in the magnet venting system. During a quench, helium gas may fail to escape, potentially causing pressure buildup and leak into the scanning room.

    Product
    MAGNETOM Cima.X (DE). Model Number: 11647158.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2666-2025·2025-10-08

    MAGNETOM Verio Dot MRI Helium Leak Risk Due to Venting Defect

    Siemens is recalling 78 MAGNETOM Verio Dot Upgrade MRI systems due to a potential ice blockage in the helium venting system that could cause pressurization and rupture during a quench event, potentially releasing helium into the scanning room.

    Product
    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2659-2025·2025-10-08

    Siemens MAGNETOM Prisma MRI Systems Recalled for Potential Helium Containment Rupture

    Siemens is recalling certain MAGNETOM Prisma MRI systems (101 units worldwide) due to a potential ice blockage in the magnet venting system that could cause helium containment rupture and leak into the scanning room.

    Product
    MAGNETOM Prisma. Model Number: 10849582.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2664-2025·2025-10-08

    MAGNETOM MRI scanners recalled for potential ice blockage in helium venting system

    Certain Siemens MRI scanners have a defect where ice can block the helium cooling system. This could cause pressure buildup, rupture the containment, and release helium gas into the scanning room.

    Product
    MAGNETOM Verio. Model Number: 10276755.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2661-2025·2025-10-08

    Siemens MRI Helium Containment Rupture Risk from Vent Blockage

    Siemens MAGNETOM Skyra fit MRI systems may have ice blockage in the venting system preventing helium gas escape during quench events, risking containment rupture and helium leak into the scanning room.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2660-2025·2025-10-08

    MRI System Helium Venting Malfunction Poses Pressure Leak Risk

    Siemens MAGNETOM Skyra MRI systems may have ice blockages in the helium venting system, potentially preventing gas escape during a quench event. This could cause pressure buildup and rupture the helium containment system, releasing helium into the scanning room.

    Product
    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2654-2025·2025-10-08

    Biograph mMR Medical Device Magnet Venting System Ice Blockage Risk

    Siemens recalls the Biograph mMR imaging device due to potential ice blockage in the magnet venting system. This could cause helium pressure build-up and containment rupture, potentially leaking helium into the scanning room.

    Product
    Biograph mMR. Model Number: 10433372.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2658-2025·2025-10-08

    Siemens MAGNETOM Lumina MRI system: potential helium venting system blockage

    Siemens is recalling MAGNETOM Lumina MRI machines due to potential ice blockage in the helium venting system that could cause pressure buildup and rupture the helium containment, releasing gas into the scanning room.

    Product
    MAGNETOM Lumina (DE). Model Number: 11344916.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2665-2025·2025-10-08

    Siemens MAGNETOM Verio Dot MRI Systems Recalled for Helium Leak Risk

    Siemens is recalling 59 MAGNETOM Verio Dot MRI systems due to potential ice blockage in the helium venting system. This could cause pressure buildup and helium leak into the scanning room.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2662-2025·2025-10-08

    MRI Scanner Helium Venting System Ice Blockage and Rupture Risk

    Siemens MAGNETOM Skyra Fit MRI systems may develop ice blockages in the helium venting system. This could prevent gas escape during a quench, causing pressure buildup and potential rupture of the helium containment.

    Product
    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2657-2025·2025-10-08

    MRI System Recall: Potential Helium Leak Risk from Magnet Venting Blockage

    The MAGNETOM Connectom.X MRI system is being recalled due to potential ice blockages in the magnet venting system. If a blockage prevents helium from venting during operation, system rupture and helium leak into the scanning room could occur.

    Product
    MAGNETOM Connectom.X. Model Number: 11371480.
    Category
    Medical Device
    Distribution
    Distributed nationwide