Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Feb 11, 2026
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Devices Moderate Feb 11, 2026
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Devices Moderate Feb 4, 2026
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
FDA Devices Moderate Jan 14, 2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Devices Moderate Dec 10, 2025
MAMMOMAT Inspiration;
FDA Devices Moderate Dec 10, 2025
MAMMOMAT Fusion;
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…
FDA Devices Critical Oct 8, 2025
Biograph mMR. Model Number: 10433372.
FDA Devices Critical Oct 8, 2025
MAGNETOM Verio. Model Number: 10276755.
FDA Devices Critical Oct 8, 2025
MAGNETOM Lumina (DE). Model Number: 11344916.
FDA Devices Critical Oct 8, 2025
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Devices Critical Oct 8, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Devices Critical Oct 8, 2025
MAGNETOM Vida Fit. Model Number: 11410481.
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Devices Critical Oct 8, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
FDA Devices Critical Oct 8, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Devices Moderate Sep 17, 2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
FDA Devices Moderate Jul 9, 2025
interventional fluoroscopic x-ray system
FDA Devices Moderate Jul 9, 2025
interventional fluoroscopic x-ray system
FDA Devices Moderate Jul 9, 2025
interventional fluoroscopic x-ray system
FDA Devices Moderate Jun 25, 2025
UROSKOP Omnia Max. Model Number: 10762473
FDA Devices Moderate Feb 5, 2025
ARTIS One Angiographic X-Ray System
FDA Devices Moderate Oct 2, 2024
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 Ultrasound …
FDA Devices Moderate Oct 2, 2024
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, wi…
FDA Devices Moderate Oct 2, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
FDA Devices Moderate Aug 14, 2024
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
FDA Devices Moderate Aug 14, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
FDA Devices Moderate Jul 31, 2024
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative to…
FDA Devices Moderate Jul 31, 2024
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and admin…
FDA Devices Moderate Jul 31, 2024
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic an…
FDA Devices Moderate Jul 3, 2024
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient de…
FDA Devices Moderate Jul 3, 2024
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…
FDA Devices Moderate Jul 3, 2024
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic d…
FDA Devices Moderate Jul 3, 2024
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…
FDA Devices Moderate May 1, 2024
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
FDA Devices Moderate May 1, 2024
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
FDA Devices Moderate Apr 24, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purp…
FDA Devices Moderate Jan 17, 2024
Sensis Vibe Hemo
FDA Devices Moderate Nov 22, 2023
Mobilett Mira wireless (VA20) mobile x-ray system(s)
FDA Devices Moderate Nov 8, 2023
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive i…
FDA Devices Moderate Nov 8, 2023
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
FDA Devices Moderate Oct 11, 2023
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Mo…
FDA Devices Moderate Sep 20, 2023
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
FDA Devices Moderate Aug 16, 2023
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
FDA Devices Moderate Aug 16, 2023
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
FDA Devices Moderate Aug 9, 2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.…
FDA Devices Moderate Aug 2, 2023
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Amb…
FDA Devices Moderate May 31, 2023
Luminos Agile Max (VE10, VF10, VF11)
FDA Devices Moderate May 31, 2023