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 systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional pr...

If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography s...
FDA device enforcement

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

Official source for SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4...
FDA device enforcement

Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM ...

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

Class IIReported ongoing

Distribution: Nationwide

Official source for Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Gu...
FDA device enforcement

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

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

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic ...
FDA device enforcement

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

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

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and flu...
FDA device enforcement

Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

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

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic stu...
FDA device enforcement

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471

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

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and ...
FDA device enforcement

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

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

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and flu...
FDA device enforcement

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Art...

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 100...
FDA device enforcement

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 i...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution

Official source for Luminos Agile Max (VE10, VF10, VF11)
FDA device enforcement

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 i...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution

Official source for Luminos dRF Max (VE10, VF10, VF11)
FDA device enforcement

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 i...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution

Official source for LUMINOS Lotus Max (VF11)
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Domestic distribution nationwide. Worldwide foreign distribution to Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosn...

Official source for Programmable Diagnostic Computer
FDA device enforcement

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ra...

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

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

Official source for ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Numbe...

Reasons in these listed records

  • If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy o...
  • This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
  • 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
  • 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

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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Where can I find older records?

Use monthly 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.

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