Siemens Medical Solutions Usa, Inc
Malvern, PA
This page shows every FDA and USDA recall linked to Siemens Medical Solutions Usa, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
822
Total Recalls
2002
First Recall
2026
Most Recent
SOMATOM X.ceed
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT A...
Feb 3, 2026
· Device
Open, Classified
NAEOTOM Alpha
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT AS...
Feb 3, 2026
· Device
Open, Classified
NAEOTOM Alpha.Prime
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo...
Feb 3, 2026
· Device
Open, Classified
NAEOTOM Alpha.Pro
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.C...
Feb 3, 2026
· Device
Open, Classified
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R;
Siemens Material Number (SMN): 11574002;
With Sof...
Jan 27, 2026
· Device
Open, Classified
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T;
Siemens Material Number (SMN): 11574003;
With Sof...
Jan 27, 2026
· Device
Open, Classified
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Jan 8, 2026
· Device
Open, Classified
MAMMOMAT Inspiration;
Dec 3, 2025
· Device
Open, Classified
MAMMOMAT Fusion;
Dec 3, 2025
· Device
Open, Classified
MAMMOMAT Revelation;
Dec 3, 2025
· Device
Open, Classified
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Nov 12, 2025
· Device
Open, Classified
MAGNETOM Skyra fit. Model Number: 10849580.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Prisma. Model Number: 10849582.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Connectom.X. Model Number: 11371480.
Sep 30, 2025
· Device
Open, Classified
Biograph mMR. Model Number: 10433372.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Vida (DE). Model Number: 11060815.
510(k): K170396, K173617, K181433, K183254, K192924, K203443, K...
Sep 30, 2025
· Device
Open, Classified
BIOGRAPH One (DE). Model Number: 11689172.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Skyra (DE). Model Number: 10432915.
510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K14...
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Cima.X (DE). Model Number: 11647158.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Vida Fit. Model Number: 11410481.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Spectra as the following:
1. MAGNETOM Spectra. Model Number: 10837643.
2. MAGNETOM Spectra (CN). M...
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Lumina (DE). Model Number: 11344916.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Verio. Model Number: 10276755.
Sep 30, 2025
· Device
Open, Classified
MAGNETOM Verio Dot. Model Number: 10684333.
Sep 30, 2025
· Device
Open, Classified
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Sep 5, 2025
· Device
Open, Classified
ARTIS is a family of dedicated angiography systems developed for single and
biplane diagnostic imaging and int...
Jun 27, 2025
· Device
Open, Classified
interventional fluoroscopic x-ray system
Jun 27, 2025
· Device
Open, Classified
interventional fluoroscopic x-ray system
Jun 27, 2025
· Device
Open, Classified
interventional fluoroscopic x-ray system
Jun 27, 2025
· Device
Open, Classified
UROSKOP Omnia Max. Model Number: 10762473
Jun 17, 2025
· Device
Open, Classified
UROSKOP Omnia. Model Number: 10094910
Jun 17, 2025
· Device
Open, Classified
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image...
Aug 7, 2024
· Device
Open, Classified
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible i...
Aug 7, 2024
· Device
Open, Classified
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible ima...
Aug 7, 2024
· Device
Open, Classified
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible i...
Aug 7, 2024
· Device
Open, Classified
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post
Processing Workstation-...
Jul 25, 2024
· Device
Open, Classified
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER
Model: 10765502-Intende...
Jul 25, 2024
· Device
Open, Classified
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool su...
Jul 25, 2024
· Device
Open, Classified
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be use...
Jul 25, 2024
· Device
Open, Classified
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining
emergency and accident...
Jun 25, 2024
· Device
Open, Classified
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunctio...
Jun 25, 2024
· Device
Open, Classified
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in
conjunction with the Siemens Mu...
Jun 25, 2024
· Device
Open, Classified
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in
conjunction with the Siemens Mu...
Jun 25, 2024
· Device
Open, Classified
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in
conjunction with the Siemens Mul...
Jun 25, 2024
· Device
Open, Classified
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunctio...
Jun 25, 2024
· Device
Open, Classified
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examin...
Jun 25, 2024
· Device
Open, Classified
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Mu...
Jun 25, 2024
· Device
Open, Classified
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining
emergency and accident patien...
Jun 25, 2024
· Device
Open, Classified