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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

747

Past Year

Class I (Serious)

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 301–320 of 747 recalls

Siemens Medical Solutions USA, Inc: ONCOR Avante Garde #5863472, ONCOR Expression #7360717, O...

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

FDAFeb 18, 2020AL, CA, DE +33 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Mo...

A software issue could potentially cause the stand and table movements to be blocked.

FDAFeb 14, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceil...

A software issue could potentially cause the stand and table movements to be blocked.

FDAFeb 14, 2020

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Nationwide

• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis zee Biplane, Model No. 10094141; Artis zee Ceiling...

A software issue could potentially cause the stand and table movements to be blocked.

FDAFeb 14, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Ysio, model no. 10281013 Product Usage: The product is...

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

FDAFeb 10, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS Pheno-Interventional Fluoroscopic X-Ray System Mod...

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

FDAJan 24, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: COHERENCE Oncologist, Model Nos. 07333680 & 07351898

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

FDAJan 16, 2020CA, FL, GA +13 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Luminos dRF Max Model: 10762471- Pr...

Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Uroskop Omnia max Model: 10762473 -...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Luminos Agile Max Model: 10762472 -...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Ysio Max - Interventional Fluoroscop...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Ysio Max, model no. 10762470 - Product Usage: The Ysio Ma...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, model no. 10762471 - Product Usage: Lu...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, Model No. 10762472 - Product Usage: Lu...

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max, model no. 10762471 - Product Usage: Lumi...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Uroskop Omnia max, Model No. 10762473 - Product Usage: Ur...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max, Model No. 10762471 - Product Usage: Lumi...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens ARTIS pheno, Model # 10849000. Interventional Fl...

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

FDADec 20, 2019Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Cios Alpha, Model Number 10308191; mobile X-Ray system d...

During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

FDANov 25, 2019Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis zee/ zeego Interventional Fluoroscopic X-Ray System...

In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.

FDANov 14, 2019TX, WA• Siemens Medical Solutions USA, Inc