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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

882

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 581–600 of 882 recalls

Siemens Medical Solutions USA, Inc.: Siemens ACUSON X300 Systems with software versions 3.0.00...

Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.

FDAJul 24, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Siemens ACUSON X300 Premium Edition Systems with software...

Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.

FDAJul 24, 2009CA, CT, FL +2 more• Siemens Medical Solutions USA, Inc.

Siemens Healthcare Diagnostics, Inc.: EasyLink Informatics System included with the Dimension V...

incorrect results may be transmitted to LIS

1...28 293031 32...45

Page 30 of 45Next

FDA

Jul 14, 2009

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc.: 4Z1c Matrix Array Transducer, model number 10033682, used...

Fire/Burn Risk

Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.

FDAJul 10, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Koodinat M/MP Patient Table used with Angiostar Model 529...

The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.

FDAJul 1, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System BUN Flex Reagent Cartridge, Catalo...

Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

FDAJun 16, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: syngo Imaging Version V31 Picture Archiving and Communica...

Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

FDAJun 1, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Somatom Definition Model AS/AS+, Model number 8098027. I...

Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.

FDAMay 29, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics Inc.: IMMULITE 2000/2500 Chemiluminescent Substrate Module For...

These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

FDAMay 15, 2009Nationwide• Siemens Healthcare Diagnostics Inc.

Siemens Medical Solutions USA, Inc.: ACUSON Sequoia C512/512SS Adv PE 10.0 System, model numbe...

Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.

FDAMay 15, 2009CA, IL, MD +3 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: ACUSON Antares 5.0 Base System, model number 10042832. D...

Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.

FDAMay 15, 2009CA, IL, MD +3 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: ACUSON Sequoia 12.X GI Base System, model number 10042701...

Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.

FDAMay 15, 2009CA, IL, MD +3 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: ACUSON Sequoia 12.X C512/512 SS Base System, model number...

Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.

FDAMay 15, 2009CA, IL, MD +3 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Mavig Portegra 2 which is an accessory to the Siemens ang...

Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

FDAMay 1, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: Symbia S Series SPECT System; Single-Photon Emission Comp...

The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.

FDAApr 22, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Symbia T Series SPECT-CT (Single-Photon Emission Computed...

The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.

FDAApr 22, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: ARTISTE MV Systems (Part Number 8139789), equipped with a...

Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment

FDAApr 9, 2009FL, MA, MI +5 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: TEE Transducer V5M, when used with the Acuson S2000 Ultra...

Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's esophagus.

FDAApr 7, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Auxiliary 2 MHz Continuous Wave (CW) transducer, model nu...

Fire/Burn Risk

Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.

FDAMar 21, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultra...

Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.

FDAMar 20, 2009IN• Siemens Medical Solutions USA, Inc.