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Siemens Medical Solutions Usa, Inc Recalls

509 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Siemens Medical Solutions Usa, Inc.

509Total Recalls
19Critical
254,569Units Affected
Mar 12, 2026Most Recent
All Recalls

Every Siemens Medical Solutions Usa, Inc Recall

Sorted by most recent. Click any recall for full details.

509 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno VE30A and VE40A, Model 10849000
Medical Devices·73 affected·Mar 12, 2026
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Medical Devices·758 affected·Mar 10, 2026
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Medical Devices·41 affected·Dec 29, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Medical Devices·1 affected·Dec 5, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAMMOMAT Inspiration;
Medical Devices·6 affected·Oct 24, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAMMOMAT Fusion;
Medical Devices·1 affected·Oct 24, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K...
Medical Devices·586 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
Biograph mMR. Model Number: 10433372.
Medical Devices·27 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio. Model Number: 10276755.
Medical Devices·154 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Medical Devices·130 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Medical Devices·3 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Medical Devices·39 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425...
Medical Devices·498 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Medical Devices·41 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Medical Devices·56 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Medical Devices·22 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Medical Devices·78 affected·Aug 28, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Medical Devices·20 affected·Aug 12, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
UROSKOP Omnia Max. Model Number: 10762473
Medical Devices·25 affected·Jun 4, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS One Angiographic X-Ray System
Medical Devices·1,140 affected·Jan 2, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic...
Diagnostic Devices·7,022 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: ...
Diagnostic Devices·321 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Diagnostic Devices·1,990 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and admin...
Cardiac Devices·3 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnost...
Cardiac Devices·7 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a d...
Cardiac Devices·2 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Medical Devices·26 affected·Jul 2, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Medical Devices·333 affected·Jul 2, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in o...
Medical Devices·2 affected·May 31, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix P...
Medical Devices·3 affected·May 31, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis ze...
Medical Devices·583 affected·Mar 21, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Diagnostic Devices·628 affected·Feb 23, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Diagnostic Devices·67 affected·Feb 23, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe Hemo
Medical Devices·331 affected·Nov 29, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides com...
Surgical Devices·12 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Surgical Devices·237 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectr...
Medical Devices·3,470 affected·Sep 1, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Medical Devices·796 affected·Jul 13, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a)...
Medical Devices·108 affected·Jul 12, 2023
CriticalFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 1084...
Diagnostic Devices·10 affected·Jun 19, 2023
CriticalFDA
Siemens Medical Solutions Usa, Inc
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number...
Diagnostic Devices·7 affected·Jun 19, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Ped...
Medical Devices·9 affected·Jun 5, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10...
Diagnostic Devices·4 affected·Mar 21, 2023