Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2026, with 794 FDA device recalls on record.
Top product codes for Siemens Medical Solutions USA, Inc.
FDA recalls by Siemens Medical Solutions USA, Inc.
10 most recent of 794- Z-2648-2026 — ARTIS icono ceiling. Model Number: 11328100.
- Z-2643-2026 — ARTIS icono floor. Model Number: 11327700.
- Z-2641-2026 — ARTIS icono biplane. Model Number: 11327600.
- Z-2642-2026 — ARTIS icono ceiling. Model Number: 11328100.
- Z-1814-2026 — ARTIS Pheno VE30A and VE40A, Model 10849000
- Z-1653-2026 — ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Z-1174-2026 — Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
- Z-1175-2026 — Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- Z-1241-2026 — NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Z-1239-2026 — SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Siemens Medical Solutions USA, Inc.
1–100 of 784- K261696 — ACUNAV Luxera 4D ICE Catheter
- K260488 — MULTIX Impact; MULTIX Impact C
- K253786 — syngo.CT Coronary Cockpit
- K253678 — MAMMOMAT B.brilliant (11372950)
- K260844 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
- K261315 — Symbia Pro.specta Q3 (11364751) +3 more
- K254184 — syngo Application Software
- K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
- K253752 — ARTIS genio floor; ARTIS icono.explore floor
- K253574 — SOMATOM X.cite; SOMATOM X.ceed
- K254016 — MI View&GO
- K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
- K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
- K250241 — Cios Select
- K251805 — syngo.CT Dual Energy
- K251481 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
- K251561 — Biograph Trinion
- K251523 — Cios Spin
- K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K251520 — Cios Alpha; Cios Flow
- K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
- K251528 — syngo.via MI Workflows; Scenium; syngo MBF
- K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
- K243145 — syngo.CT LVO Detection
- K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K241757 — syngo.CT Dual Energy
- K242523 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
- K243299 — ACUSON Redwood Diagnostic Ultrasound System
- K243186 — Symbia Pro.specta Q3 (11364751) +3 more
- K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
- K241569 — syngo Application Software
- K241295 — SOMATOM On.site
- K242275 — syngo.via MI Workflows; Scenium; syngo MBF
- K242300 — MI View&GO
- K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
- K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
- K233613 — ACUSON SC2000 Diagnostic Ultrasound System
- K232799 — syngo.via RT Image Suite
- K240608 — MAGNETOM Viato.Mobile
- K233657 — NAEOTOM Alpha
- K233539 — MAMMOMAT B.brilliant
- K233650 — SOMATOM go.Up +7 more
- K232322 — MAGNETOM Terra; MAGNETOM Terra.X
- K232431 — syngo.CT Brain Hemorrhage
- K233748 — CIARTIC Move (VB10)
- K232765 — MAGNETOM Cima.X Fit
- K233677 — Biograph VK10
- K232136 — syngo.CT Applications
- K232535 — MAGNETOM Sola; MAGNETOM Altea
- K230955 — syngo Application Software
- K231587 — MAGNETOM Cima.X
- K230949 — ARTIS pheno (VE30A)
- K230950 — ARTIS icono (VE30A)
- K232206 — SOMATOM Pro.Pulse
- K232155 — syngo.CT Dual Energy
- K232000 — syngo.via MI Workflows; Scenium; syngo MBF
- K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit
- K231617 — MAGNETOM Free.Max; MAGNETOM Free.Star
- K232145 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
- K233270 — AcuNav Crystal Ultrasound Catheter
- K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
- K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
- K223812 — Sensis Vibe (VD15)
- K232482 — MAGNETOM Viato.Mobile
- K231833 — Biograph Vision.X and Biograph Vision.X Edge
- K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
- K231102 — Symbia Pro.specta VA20A Family
- K223343 — MAGNETOM Amira; MAGNETOM Sempra
- K213805 — MAGNETOM Vida
- K230207 — ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
- K223735 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
- K223363 — MAMMOVISTA B.smart (VB70)
- K223547 — Biograph Vision Quadra PET/CT System
- K223410 — Cios Select (VA21) Flat Panel
- K223409 — Cios Select (VA21) Image Intensifier
- K222428 — Syngo Dynamics (Version VA40F)
- K222361 — AI-Rad Companion (Musculoskeletal)
- K221305 — AI-Rad Companion Organs RT
- K221733 — MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
- K220783 — syngo.via RT Image Suite
- K222172 — MI View&GO
- K221190 — ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
- K221516 — ARTIS icono (Ceiling Configuration)
- K221727 — syngo.CT Extended Functionality
- K220814 — NAEOTOM Alpha, Scan&GO Software
- K220409 — ARTIS pheno (VE21) System
- K220432 — ARTIS icono (VE21) System
- K220575 — MAGNETOM Free.Max, MAGNETOM Free.Star
- K221500 — ACUSON Sequoia Diagnostic Ultrasound System
- K220832 — syngo Dynamics (Version VA40E)
- K220919 — MULTIX Impact E
- K221219 — syngo.CT CaScoring
- K220589 — MAGNETOM Skyra Fit
- K220939 — MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
- K220151 — MAGNETOM Avanto Fit
- K212889 — Syngo.CT Dual Energy
- K220425 — MAGNETOM Vida, MAGNETOM Sola
- K220450 — syngo.CT Applications
- K213693 — MAGNETOM Vida with syngo MR XA50A
- K213487 — ACUSON P500 Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.