Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc appears in FDA public data with 795 recalls — including 16 Class I (most serious) —, 782 510(k) clearances, 28 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2648-2026, Class II) was initiated on June 8, 2026. Its most recent 510(k) clearance was granted on June 25, 2026.
Summary
- Total Recalls
- 795 (16 Class I)
- 510(k) Clearances
- 782
- Inspections
- 28
- Compliance Actions
- 0
Known Names
siemens medical solutions usa, siemens medical solutions, usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2648-2026 | Class II | ARTIS icono ceiling. Model Number: 11328100. | June 8, 2026 |
| Z-2641-2026 | Class II | ARTIS icono biplane. Model Number: 11327600. | May 20, 2026 |
| Z-2643-2026 | Class II | ARTIS icono floor. Model Number: 11327700. | May 20, 2026 |
| Z-2642-2026 | Class II | ARTIS icono ceiling. Model Number: 11328100. | May 20, 2026 |
| Z-1814-2026 | Class II | ARTIS Pheno VE30A and VE40A, Model 10849000 | March 12, 2026 |
| Z-1653-2026 | Class II | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, | March 10, 2026 |
| Z-2206-2026 | Class II | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Mod | March 9, 2026 |
| Z-2205-2026 | Class II | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | March 9, 2026 |
| Z-1175-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 1157400 | December 29, 2025 |
| Z-1174-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 1157400 | December 29, 2025 |
| Z-1242-2026 | Class II | NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdens | December 19, 2025 |
| Z-1239-2026 | Class II | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensiti | December 19, 2025 |
| Z-1240-2026 | Class II | NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensitie | December 19, 2025 |
| Z-1241-2026 | Class II | NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperde | December 19, 2025 |
| Z-0999-2026 | Class II | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | December 5, 2025 |
| Z-0879-2026 | Class II | MAMMOMAT Fusion; | October 24, 2025 |
| Z-0877-2026 | Class II | MAMMOMAT Revelation; | October 24, 2025 |
| Z-0878-2026 | Class II | MAMMOMAT Inspiration; | October 24, 2025 |
| Z-0431-2026 | Class I | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | October 1, 2025 |
| Z-2662-2025 | Class I | MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. | August 28, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253786 | syngo.CT Coronary Cockpit | June 25, 2026 |
| K253678 | MAMMOMAT B.brilliant (11372950) | June 18, 2026 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSO | June 16, 2026 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symb | May 21, 2026 |
| K254184 | syngo Application Software | April 29, 2026 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | April 24, 2026 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | April 23, 2026 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | March 20, 2026 |
| K254016 | MI View&GO | February 10, 2026 |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | November 17, 2025 |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | November 13, 2025 |
| K250241 | Cios Select | November 4, 2025 |
| K251805 | syngo.CT Dual Energy | October 15, 2025 |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACU | August 20, 2025 |
| K251561 | Biograph Trinion | July 31, 2025 |
| K251523 | Cios Spin | July 29, 2025 |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | July 28, 2025 |
| K251520 | Cios Alpha; Cios Flow | July 9, 2025 |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | July 3, 2025 |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | July 3, 2025 |