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. Source coverage and dates.

Records and reported status

FDA device enforcement

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 1132810...
FDA device enforcement

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 IIReported ongoing

Distribution: US and Worldwide

Official source for ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
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-...

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 IIReported ongoing

Distribution: US and Worldwide

Official source for ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling ...
FDA device enforcement

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

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 IIReported 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...
FDA device enforcement

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

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 IIReported 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...
FDA device enforcement

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Class IIReported 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...
FDA device enforcement

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Class IIReported 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...
FDA device enforcement

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Class IIReported 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...
FDA device enforcement

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Class IIReported 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...
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. and OUS

Official source for LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA device enforcement

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 IIReported 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;
FDA device enforcement

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 IIReported 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;
FDA device enforcement

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 IIReported 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;
FDA device enforcement

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 IReported ongoing

Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian.

Official source for MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA device enforcement

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 IReported 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.

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.

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