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 |
|---|---|---|---|
| Jun 8, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds t... | Class II |
| May 20, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential for loss of movement capability after adjusting the detector lift h... | Class II |
| May 20, 2026 | ARTIS icono biplane. Model Number: 11327600. | Potential for loss of movement capability after adjusting the detector lift h... | Class II |
| May 20, 2026 | ARTIS icono floor. Model Number: 11327700. | Potential for loss of movement capability after adjusting the detector lift h... | Class II |
| Mar 12, 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | During 3D acquisitions, lighter and darker patient images may be captured, wh... | Class II |
| Mar 10, 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 1084900... | During patient examinations, the system may sporadically display a major incr... | Class II |
| Mar 9, 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | During patient examinations, the system may sporadically display a 0 x-ray ... | Class II |
| Mar 9, 2026 | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ... | During patient examinations, the system may sporadically display a 0 x-ray ... | Class II |
| 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 |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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