Siemens Medical Solutions USA, Inc

Complete recall history across all FDA and CPSC categories — 615 total recalls

Siemens Medical Solutions USA, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (615)

FDA medical device enforcement actions by Siemens Medical Solutions USA, Inc. Showing most recent 50.

Date Product Reason Class
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped a... Class II
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped a... Class II
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applicatio... Class II
Dec 19, 2025 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... To remove the software applications from certain CT systems as the applicatio... Class II
Dec 19, 2025 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... To remove the software applications from certain CT systems as the applicatio... Class II
Dec 19, 2025 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... To remove the software applications from certain CT systems as the applicatio... Class II
Dec 5, 2025 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max syst... Class II
Oct 24, 2025 MAMMOMAT Revelation; There were instances where the operator table was sold together with a bus-in... Class II
Oct 24, 2025 MAMMOMAT Fusion; There were instances where the operator table was sold together with a bus-in... Class II
Oct 24, 2025 MAMMOMAT Inspiration; There were instances where the operator table was sold together with a bus-in... Class II
Oct 1, 2025 MAGNETOM Cima.X Upgrade. Model Number: 11689304. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Verio Dot. Model Number: 10684333. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 BIOGRAPH One (DE). Model Number: 11689172. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Prisma. Model Number: 10849582. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Connectom.X. Model Number: 11371480. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Verio Dot Upgrade. Model Number: 10684334. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Cima.X (DE). Model Number: 11647158. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Skyra fit. Model Number: 10849580. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Vida Fit. Model Number: 11410481. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K... There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837... There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Lumina (DE). Model Number: 11344916. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Verio. Model Number: 10276755. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 Biograph mMR. Model Number: 10433372. There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 28, 2025 MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111... There is a potential for an ice blockage to form or currently exist within th... Class I
Aug 12, 2025 Artis Pheno. Image-Intensified Flouroscopic X-Ray System. Limited system movements after startup . Class II
Jun 4, 2025 UROSKOP Omnia. Model Number: 10094910 A resistor in the frequency inverter may strongly overheat potentially igniti... Class II
Jun 4, 2025 UROSKOP Omnia Max. Model Number: 10762473 A resistor in the frequency inverter may strongly overheat potentially igniti... Class II
May 15, 2025 ARTIS is a family of dedicated angiography systems developed for single and ... In very rare situations, communication between the sensor measuring dose appl... Class II
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose appl... Class II
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose appl... Class II
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose appl... Class II
Jan 2, 2025 ARTIS One Angiographic X-Ray System A potential issue with ARTIS One systems was identified. In very rare situat... Class II
Jul 3, 2024 Sensis Vibe systems with software version VD15B-Intended to be used as a diag... If the Sensis documentation functionality is used during adding of once-per-s... Class II
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with AXIOM Se... If the Sensis documentation functionality is used during adding of once-per-s... Class II
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... If the Sensis documentation functionality is used during adding of once-per-s... Class II
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with Sensis Hi... If the Sensis documentation functionality is used during adding of once-per-s... Class II
Jul 2, 2024 Multitom Rax -Intended to visualize anatomical structures by converting an x-... The support arm may unintentionally lower resulting in injury to persons when... Class II
Jul 2, 2024 Luminos dRF Max- Intended to visualize anatomical structures by converting an... The support arm may unintentionally lower resulting in injury to persons when... Class II
Jul 2, 2024 Luminos Agile Max -Intended to visualize anatomical structures by converting ... The support arm may unintentionally lower resulting in injury to persons when... Class II
Jul 2, 2024 LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ... The support arm may unintentionally lower resulting in injury to persons when... Class II
May 31, 2024 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has b... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II
May 31, 2024 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... Short circuit in the power supply unit (PSU) of the Touch Display may lead to... Class II

View all 615 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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