FDA recall record · openFDA
Siemens Medical Solutions USA, Inc
80 FDA recalls on record (2023–2026) — 80 device. 80 still ongoing.
16
Class I (most serious)
64
Class II
0
Class III
80
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a 15
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire 9
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall s 4
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, 4
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding softw 4
Recalls
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1 Class I 2025-08-28 Biograph mMR. Model Number: 10433372. Class I 2025-08-28 MAGNETOM Verio. Model Number: 10276755. Class I 2025-08-28 MAGNETOM Lumina (DE). Model Number: 11344916. Class I 2025-08-28 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe Class I 2025-08-28 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. Class I 2025-08-28 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, Class I 2025-08-28 MAGNETOM Vida Fit. Model Number: 11410481. Class I 2025-08-28 MAGNETOM Skyra fit. Model Number: 10849580. Class I 2025-08-28 MAGNETOM Cima.X (DE). Model Number: 11647158. Class I 2025-08-28 MAGNETOM Verio Dot Upgrade. Model Number: 10684334. Class I 2025-08-28 MAGNETOM Connectom.X. Model Number: 11371480. Class I 2025-08-28 MAGNETOM Prisma. Model Number: 10849582. Class I 2025-08-28 BIOGRAPH One (DE). Model Number: 11689172. Class I 2025-08-28 MAGNETOM Cima.X Upgrade. Model Number: 11689304. Class I 2025-10-01 MAGNETOM Verio Dot. Model Number: 10684333. Class I 2025-08-28 ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. Class II 2026-03-10 ARTIS Pheno VE30A and VE40A, Model 10849000 Class II 2026-03-12 ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS i Class II 2026-03-09 ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system Class II 2026-03-09 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve Class II 2025-12-29 Artis Pheno. Image-Intensified Flouroscopic X-Ray System. Class II 2025-08-12 MAMMOMAT Inspiration; Class II 2025-10-24 UROSKOP Omnia Max. Model Number: 10762473 Class II 2025-06-04 MAMMOMAT Fusion; Class II 2025-10-24 interventional fluoroscopic x-ray system Class II 2025-05-15 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE Class II 2025-12-19 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS Class II 2025-12-19 ARTIS One Angiographic X-Ray System Class II 2025-01-02 interventional fluoroscopic x-ray system Class II 2025-05-15 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Class II 2025-12-05 interventional fluoroscopic x-ray system Class II 2025-05-15 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS Class II 2025-12-19 UROSKOP Omnia. Model Number: 10094910 Class II 2025-06-04 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Ve Class II 2025-12-29 MAMMOMAT Revelation; Class II 2025-10-24 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention Class II 2025-05-15 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT AS Class II 2025-12-19 LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode Class II 2024-07-02 ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G Class II 2024-02-23 AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as wel Class II 2024-05-31 Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a dia Class II 2024-07-03 ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2. Class II 2024-08-15 ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultraso Class II 2024-08-15 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Class II 2024-05-31 Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be u Class II 2024-07-03 ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software Class II 2024-08-15 ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V Class II 2024-02-23 Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1 Class II 2024-03-21 Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod Class II 2024-07-02 Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended Class II 2024-07-03 AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a Class II 2024-05-31 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Class II 2024-05-31 AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO Class II 2024-05-31 AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients Class II 2024-05-31 Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Class II 2024-07-02 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO Class II 2024-05-31 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a Class II 2024-05-31 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emerge Class II 2024-05-31 Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num Class II 2024-07-02 Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting h Class II 2024-07-03 ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: Class II 2024-02-23 Sensis Vibe Hemo Class II 2023-11-29 ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # Class II 2023-02-02 The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sens Class II 2023-07-12 ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment Class II 2023-09-12 ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate Class II 2023-06-19 ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s Class II 2023-02-02 Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 Class II 2023-09-12 ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 Class II 2023-07-13 ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Class II 2023-06-19 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Class II 2023-06-05 ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Ma Class II 2023-03-21 SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Class II 2023-01-16 (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic Class II 2023-09-01 SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge Class II 2023-01-16 Mobilett Mira wireless (VA20) mobile x-ray system(s) Class II 2023-10-05 SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission Class II 2023-01-16 ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 Class II 2023-10-17 ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedur Class II 2023-06-19
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.