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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

1000

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 261–280 of 1121 recalls

Siemens Medical Solutions USA, Inc: Sensis/ Sensis Vibe Hemo systems with VD12A software as f...

Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions

FDAMar 4, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP...

SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

FDAMar 3, 2021Nationwide• Siemens Medical Solutions USA, Inc

Acetaminophen Tablets (A-S Medication) – labeling mixup (2021)

1...12 131415 16...57

Page 14 of 57Next

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

Class IHigh

FDAMar 2, 2021Nationwide• A-S Medication Solutions LLC.

Siemens Medical Solutions USA, Inc: Interventional Fluoroscopic X-Ray System - Product Usage:...

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

FDAFeb 26, 2021Nationwide• Siemens Medical Solutions USA, Inc

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

Stryker Sustainability Solutions: Stryker Sustainability Solutions REF HARH36 Ethicon Endo-...

Product was distributed without receiving regulatory clearance.

FDAJan 19, 2021Nationwide• Stryker Sustainability Solutions

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

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

HCG 11,000 IU (Complete Pharmacy) – Potency Testing (2020)

CGMP deviations: Lack of potency testing.

Class IIModerate

FDANov 20, 2020Nationwide• Complete Pharmacy and Medical Solutions, LLC.

Human Chorionic Gonadotropin (Complete Pharmacy) – Potency Testing Issue (2020)

CGMP deviations: Lack of potency testing.

Class IIModerate

FDANov 20, 2020Nationwide• Complete Pharmacy and Medical Solutions, LLC.

HCG 1,250 IU (Complete Pharmacy) – Potency Testing (2020)

CGMP deviations: Lack of potency testing.

Class IIModerate

FDANov 20, 2020Nationwide• Complete Pharmacy and Medical Solutions, LLC.

Human Chorionic Gonadotropin (Complete Pharmacy) – Potency Testing Issue (2020)

CGMP deviations: Lack of potency testing.

Class IIModerate

FDANov 20, 2020Nationwide• Complete Pharmacy and Medical Solutions, LLC.

Levocetirizine Tablets (InvaTech) – Stability Failure (2020)

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

Class IIILow

FDANov 11, 2020Nationwide• InvaTech Pharma Solutions, LLC

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, Model no. 10094910 - Product Usage: a soli...

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 Max, Model no. 10762473 - Product Usage: a ...

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