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Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. Recalls

All product recalls associated with Siemens Medical Solutions USA, Inc..

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Recall Summary

Total Recalls

128

Past Year

25

Class I (Serious)

0

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 128 recalls

Siemens Medical Solutions USA, Inc.: SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R...

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

FDAJan 16, 2023Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: SIEMENS Biograph Horizon 3R Mobile; System, Tomography, C...

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

FDAJan 16, 2023Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Software : myNeedle Guide 2D license, myNeedle Guide 2D A...

In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

Page 4 of 7Next

Moderate

FDADec 22, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max with software VE10 & VF11- A diagnostic...

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF with software VD10- A diagnostic imaging syst...

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile with software VC10 - A diagnostic imaging s...

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Uroskop Omnia Max with software VE10 & VF11- A diagnostic...

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max with software VE10, VF10, VF11- A diagnos...

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: System Material # Artis zee floor 10094135 Artis zee cei...

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Mechanical connection between the tabletop and table base may be lost.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 an...

There is potential for the footrest to detach from the patient table during use.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Luminos Agile

There is potential for the footrest to detach from the patient table during use.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: LUMINOS Lotus Max (VF11)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max (VE10, VF10, VF11)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max (VE10, VF10, VF11)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Programmable Diagnostic Computer

The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

FDANov 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with s...

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

FDANov 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS pheno, Interventional fluoroscopic x-ray system, Mo...

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

FDASep 20, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis Q floor- Model No. 10848280 Artis Q ceiling- Model ...

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc