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Siemens Medical Solutions USA Inc.

FDA Regulatory Profile

Summary

Total Recalls
787 (16 Class I)
510(k) Clearances
774
Inspections
28
Compliance Actions
0

Known Names

siemens medical solutions usa, siemens medical solutions, usa

Recent Recalls

NumberClassProductDate
Z-1175-2026Class IIInterventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 1157400December 29, 2025
Z-1174-2026Class IIInterventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 1157400December 29, 2025
Z-1241-2026Class IINAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel HyperdeDecember 19, 2025
Z-1240-2026Class IINAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel HyperdensitieDecember 19, 2025
Z-1242-2026Class IINAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel HyperdensDecember 19, 2025
Z-1239-2026Class IISOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel HyperdensitiDecember 19, 2025
Z-0999-2026Class IILUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471December 5, 2025
Z-0878-2026Class IIMAMMOMAT Inspiration;October 24, 2025
Z-0879-2026Class IIMAMMOMAT Fusion;October 24, 2025
Z-0877-2026Class IIMAMMOMAT Revelation;October 24, 2025
Z-0431-2026Class IMAGNETOM Cima.X Upgrade. Model Number: 11689304.October 1, 2025
Z-2666-2025Class IMAGNETOM Verio Dot Upgrade. Model Number: 10684334.August 28, 2025
Z-2656-2025Class IMAGNETOM Cima.X (DE). Model Number: 11647158.August 28, 2025
Z-2667-2025Class IMAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K19292August 28, 2025
Z-2662-2025Class IMAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.August 28, 2025
Z-2657-2025Class IMAGNETOM Connectom.X. Model Number: 11371480.August 28, 2025
Z-2658-2025Class IMAGNETOM Lumina (DE). Model Number: 11344916.August 28, 2025
Z-2663-2025Class IMAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM SpectAugust 28, 2025
Z-2664-2025Class IMAGNETOM Verio. Model Number: 10276755.August 28, 2025
Z-2659-2025Class IMAGNETOM Prisma. Model Number: 10849582.August 28, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K254016MI View&GOFebruary 10, 2026
K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemNovember 17, 2025
K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemNovember 13, 2025
K250241Cios SelectNovember 4, 2025
K251805syngo.CT Dual EnergyOctober 15, 2025
K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUAugust 20, 2025
K251561Biograph TrinionJuly 31, 2025
K251523Cios SpinJuly 29, 2025
K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJuly 28, 2025
K251520Cios Alpha; Cios FlowJuly 9, 2025
K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; July 3, 2025
K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsJuly 3, 2025
K251528syngo.via MI Workflows; Scenium; syngo MBFJuly 3, 2025
K243145syngo.CT LVO DetectionApril 10, 2025
K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeFebruary 12, 2025
K241757syngo.CT Dual EnergyJanuary 3, 2025
K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUNovember 19, 2024
K243299ACUSON Redwood Diagnostic Ultrasound SystemNovember 15, 2024
K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); SOctober 30, 2024
K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheOctober 22, 2024