--- title: "Siemens Medical Solutions USA, Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Siemens Medical Solutions USA, Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/siemens-medical-solutions-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Siemens Medical Solutions USA, Inc recall records **141** reported ongoing 162 records in this archive. Latest source date Jun 8, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 8, 2026 FDA device enforcement ### [ARTIS icono ceiling. Model Number: 11328100.](https://isitonrecall.com/recall/fda-device-z-2648-2026-artis-icono-ceiling-model-number-11328100/) Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC. [Official source for ARTIS icono ceiling. Model Number: 11328100.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2648-2026%22) May 20, 2026 FDA device enforcement ### [ARTIS icono biplane. Model Number: 11327600.](https://isitonrecall.com/recall/fda-device-z-2641-2026-artis-icono-biplane-model-number-11327600/) Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ARTIS icono biplane. Model Number: 11327600.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2641-2026%22) May 20, 2026 FDA device enforcement ### [ARTIS icono ceiling. Model Number: 11328100.](https://isitonrecall.com/recall/fda-device-z-2642-2026-artis-icono-ceiling-model-number-11328100/) Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ARTIS icono ceiling. Model Number: 11328100.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2642-2026%22) May 20, 2026 FDA device enforcement ### [ARTIS icono floor. Model Number: 11327700.](https://isitonrecall.com/recall/fda-device-z-2643-2026-artis-icono-floor-model-number-11327700/) Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ARTIS icono floor. Model Number: 11327700.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2643-2026%22) Mar 12, 2026 FDA device enforcement ### [ARTIS Pheno VE30A and VE40A, Model 10849000](https://isitonrecall.com/recall/fda-device-z-1814-2026-artis-pheno-ve30a-and-ve40a-model-10849000/) During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused b... Class II Reported ongoing Distribution: U.S. and O.U.S. [Official source for ARTIS Pheno VE30A and VE40A, Model 10849000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1814-2026%22) Mar 10, 2026 FDA device enforcement ### [ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.](https://isitonrecall.com/recall/fda-device-z-1653-2026-artis-pheno-and-artis-icono-biplane-floor-and-ceiling-model-numbers-10849000-11327600-11328100-11327/) During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settin... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 1132810...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1653-2026%22) Mar 9, 2026 FDA device enforcement ### [ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system](https://isitonrecall.com/recall/fda-device-z-2205-2026-artis-pheno-model-10849000-interventional-fluoroscopic-x-ray-system/) During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray... Class II Reported ongoing Distribution: US and Worldwide [Official source for ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2205-2026%22) Mar 9, 2026 FDA device enforcement ### [ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-...](https://isitonrecall.com/recall/fda-device-z-2206-2026-artis-icono-biplane-floor-and-ceiling-artis-icono-biplane-model-11327600-artis-icono-ceiling-model-1/) During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray... Class II Reported ongoing Distribution: US and Worldwide [Official source for ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2206-2026%22) Dec 29, 2025 FDA device enforcement ### [Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02](https://isitonrecall.com/recall/fda-device-z-1174-2026-interventional-fluoroscopic-x-ray-system-luminos-q-namix-r-siemens-material-number-smn-11574002-with/) Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, N... [Official source for Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1174-2026%22) Dec 29, 2025 FDA device enforcement ### [Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02](https://isitonrecall.com/recall/fda-device-z-1175-2026-interventional-fluoroscopic-x-ray-system-luminos-q-namix-t-siemens-material-number-smn-11574003-with/) Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, N... [Official source for Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1175-2026%22) Dec 19, 2025 FDA device enforcement ### [SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS](https://isitonrecall.com/recall/fda-device-z-1239-2026-somatom-x-ceed-software-applications-syngo-ct-brain-quantification-syngo-ct-vessel-hyperdensities-sy/) To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. [Official source for SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensitie...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1239-2026%22) Dec 19, 2025 FDA device enforcement ### [NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS](https://isitonrecall.com/recall/fda-device-z-1240-2026-naeotom-alpha-software-applications-syngo-ct-brain-quantification-syngo-ct-vessel-hyperdensities-syn/) To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. [Official source for NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1240-2026%22) Dec 19, 2025 FDA device enforcement ### [NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS](https://isitonrecall.com/recall/fda-device-z-1241-2026-naeotom-alpha-prime-software-applications-syngo-ct-brain-quantification-syngo-ct-vessel-hyperdensiti/) To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. [Official source for NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperden...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1241-2026%22) Dec 19, 2025 FDA device enforcement ### [NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS](https://isitonrecall.com/recall/fda-device-z-1242-2026-naeotom-alpha-pro-software-applications-syngo-ct-brain-quantification-syngo-ct-vessel-hyperdensities/) To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. [Official source for NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1242-2026%22) Dec 5, 2025 FDA device enforcement ### [LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471](https://isitonrecall.com/recall/fda-device-z-0999-2026-luminos-lotus-max-model-11574100-and-luminos-drf-max-model-10762471/) A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be inco... Class II Reported ongoing Distribution: U.S. and OUS [Official source for LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0999-2026%22) Oct 24, 2025 FDA device enforcement ### [MAMMOMAT Revelation;](https://isitonrecall.com/recall/fda-device-z-0877-2026-mammomat-revelation/) There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India. [Official source for MAMMOMAT Revelation;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0877-2026%22) Oct 24, 2025 FDA device enforcement ### [MAMMOMAT Inspiration;](https://isitonrecall.com/recall/fda-device-z-0878-2026-mammomat-inspiration/) There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India. [Official source for MAMMOMAT Inspiration;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0878-2026%22) Oct 24, 2025 FDA device enforcement ### [MAMMOMAT Fusion;](https://isitonrecall.com/recall/fda-device-z-0879-2026-mammomat-fusion/) There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India. [Official source for MAMMOMAT Fusion;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0879-2026%22) Oct 1, 2025 FDA device enforcement ### [MAGNETOM Cima.X Upgrade. Model Number: 11689304.](https://isitonrecall.com/recall/fda-device-z-0431-2026-magnetom-cima-x-upgrade-model-number-11689304/) There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable... Class I Reported ongoing Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian. [Official source for MAGNETOM Cima.X Upgrade. Model Number: 11689304.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0431-2026%22) Aug 28, 2025 FDA device enforcement ### [Biograph mMR. Model Number: 10433372.](https://isitonrecall.com/recall/fda-device-z-2654-2025-biograph-mmr-model-number-10433372/) There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containme... Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh,... [Official source for Biograph mMR. Model Number: 10433372.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2654-2025%22) ## Reasons in these listed records - Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. - Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. - During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisi... - During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging condi... These examples come from this result page and are not a ranking of every recall reason. ## Checking Siemens Medical Solutions USA, Inc ### Is there a recall on siemens medical solutions usa, inc right now? This archive contains 162 records, including 141 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Siemens Medical Solutions USA, Inc](https://isitonrecall.com/check/?q=Siemens%20Medical%20Solutions%20USA%2C%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)