The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc.

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

What the numbers show

Total
796
Critical
16
Severe
69
Most recent
2026-07-08

Of the 796 recalls from Siemens Medical Solutions USA, Inc. we have scored against our rubric, 16 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 69 (9%) are Severe.

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 796

  • HighFDA (Devices)·Z-2642-2026·2026-07-08

    ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall

    Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2026·2026-07-08

    ARTIS icono floor Medical Imaging System Detector Movement Loss Recall

    Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.

    Product
    ARTIS icono floor. Model Number: 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2026·2026-07-08

    ARTIS icono ceiling medical imaging monitor suspension system

    Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2641-2026·2026-07-08

    ARTIS icono biplane medical imaging system detector lift malfunction

    Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.

    Product
    ARTIS icono biplane. Model Number: 11327600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2026·2026-06-10

    ARTIS pheno systems may display zero dose while dose is applied

    ARTIS pheno interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.

    Product
    ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2206-2026·2026-06-10

    ARTIS Icono systems may display zero dose while dose is applied

    ARTIS Icono interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.

    Product
    ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1814-2026·2026-04-22

    ARTIS Pheno 3D acquisitions may capture uneven patient image brightness

    ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.

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

    Siemens ARTIS imaging systems may display an inflated patient dose reading

    Siemens ARTIS pheno and ARTIS Icono systems may sporadically display a major increase in the x-ray dose applied, although the actual dose applied remains within system settings and regulatory limits.

    Product
    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2026·2026-02-11

    NAEOTOM Alpha.Pro software applications recalled over missing FDA clearance

    Siemens is removing three software applications from two NAEOTOM Alpha.Pro CT systems because the applications 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
  • ModerateFDA (Devices)·Z-1241-2026·2026-02-11

    CT software applications recalled because they lack FDA clearance

    Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.

    Product
    NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1240-2026·2026-02-11

    NAEOTOM Alpha software applications recalled because they lack FDA clearance

    Siemens is removing three software applications from 88 NAEOTOM Alpha CT systems because the applications have not received FDA 510(k) clearance.

    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-1239-2026·2026-02-11

    SOMATOM X.ceed software applications recalled over missing FDA clearance

    Siemens is removing three software applications from two SOMATOM X.ceed CT systems because the applications have not received FDA 510(k) clearance.

    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-1174-2026·2026-02-04

    Roasted pumpkin tamales recalled over potential Listeria monocytogenes contamination

    Prima Vera Nueva is recalling 9,656 packages (4 tamales per package) of Roasted Pumpkin & White Cheddar Tamales over potential contamination with Listeria monocytogenes.

    Product
    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2026·2026-02-04

    Q.namix T fluoroscopy systems recalled over unflipped and mismatched images

    Siemens is recalling 7 units of the LUMINOS Q.namix T fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.

    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
  • ModerateFDA (Devices)·Z-0999-2026·2026-01-14

    Radiography systems recalled because collimation may be incorrect between programs

    Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.

    Product
    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0431-2026·2025-11-19

    MRI upgrade recalled over ice blockage in helium venting paths

    Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.

    Product
    MAGNETOM Cima.X Upgrade. Model Number: 11689304.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk

    Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2656-2025·2025-10-08

    MAGNETOM Cima.X systems recalled over ice blockage in helium venting system

    Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Cima.X (DE). Model Number: 11647158.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2663-2025·2025-10-08

    MAGNETOM Spectra MRI systems recalled over helium venting ice blockage

    Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2659-2025·2025-10-08

    MAGNETOM Prisma MRI systems recalled over helium venting ice blockage

    Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Prisma. Model Number: 10849582.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2668-2025·2025-10-08

    MAGNETOM Vida Fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 41 MAGNETOM Vida Fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Vida Fit. Model Number: 11410481.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2661-2025·2025-10-08

    MAGNETOM Skyra fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide