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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

613

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 161–180 of 613 recalls

Siemens Medical Solutions USA, Inc.: Product Label - ACUSON Sequoia *** Power Input: 100-240V~...

The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.

FDAFeb 4, 2021AL, AK, AZ +41 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Sensis / Sensis Vibe systems with software version VD12 a...

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

FDAJan 27, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS Icono biplane Model:11327600 ARTIS Icono floor syst...

Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system

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FDADec 18, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

FDANov 30, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM Force, Definition AS, Definition Edge, Definition...

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

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

Siemens Medical Solutions USA, Inc: Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Im...

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

FDAOct 21, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Artis one systems with a Display Port transceiver...

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

FDASep 21, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS Icono Interventional Fluoroscopic X-Ray system - Pr...

There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.

FDASep 18, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Uroskop Omnia Max, Model no. 10762473 - Product Usage: a ...

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

FDASep 9, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Uroskop Omnia, Model no. 10094910 - Product Usage: a soli...

FDASep 9, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Software: Syngo.via RT Image Suite software version VA30_...

Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

FDAAug 19, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: Symbia S-Series and Symbia T-Series - Product Usage: Int...

This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.

FDAAug 14, 2020Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Artis zee or Artis Q systems (listed below) - Product Usa...

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

FDAAug 3, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Cios Alpha, Image-Intensified Fluoroscopic X-Ray System ...

Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

FDAJul 30, 2020AZ, CA, FL +12 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Cios Spin, Image-Intensified Fluoroscopic X-Ray System T...

Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

FDAJul 30, 2020AZ, CA, FL +12 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Sensis Vibe Hemo system in combination with the M...

The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost

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

Siemens Medical Solutions USA, Inc: Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - M...

Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.

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

Siemens Medical Solutions USA, Inc: syngo.via RT Image Suite with software versions syngo.via...

If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.

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

Siemens Medical Solutions USA, Inc: Software versions syngo.CT VB20 or VB20_SP1 in the follow...

Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

FDAJun 22, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: ACUSON AcuNav Volume Intracardiac Echocardiography Cathet...

Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

FDAMay 22, 2020AZ, CA, FL +16 more• Siemens Medical Solutions USA, Inc.