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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 321–340 of 613 recalls

Siemens Medical Solutions USA, Inc.: 10041461 ACUSON S2000, manufactured by Siemens Medical So...

ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

FDAOct 2, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: 10032746 Acuson Antares PE Product Version 5.0, manufactu...

ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

FDAOct 2, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: 10430054 Acuson with Physio Module, manufactured by Sieme...

ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

FDAOct 2, 2009Nationwide

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Page 17 of 31Next

• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Acuson Antares Ultrasound System Diagnostic Ultrasound sy...

Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.

FDASep 30, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Syngo Imaging XS VA60 and VA70 in combination with a NAS ...

Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.

FDASep 30, 2009IN, NY, OH• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Syngo Imaging XS VA60 and VA70 in combination with JPEG C...

Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.

FDASep 29, 2009CA, FL, GA +13 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Syngo Imaging XS VA60 and VA70 in combination with JPEG C...

FDASep 29, 2009CA, FL, GA +13 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray S...

possible injury to hand/fingers

FDASep 23, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens ARTISTE syngo RT Therapist, Therapist Assist, The...

A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.

FDASep 10, 2009Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: V5M TEE Transducer, when used with an ACUSON S2000 ultras...

If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.

FDAAug 28, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: LANTIS oncology Information System, an accessory to the L...

When editing the note type of a previously entered note, then reverting to the original type, data may be lost.

FDAAug 21, 2009AL, DE, MA +6 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA Inc.: Siemens Biograph mCT-S 40, model number 10248671. Medica...

In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

FDAAug 11, 2009Nationwide• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Siemens Biograph mCT-S 64, model number 10248672. Medica...

In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

FDAAug 11, 2009Nationwide• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Siemens Biograph mCt-X, model number 10248670. Medical I...

In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

FDAAug 11, 2009Nationwide• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA, Inc.: Acuson X300 systems at software versions 1.00.00 to 1.0.1...

Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.

FDAJul 30, 2009Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Linear Medical Accelerator ARTISTE MV systems, when equip...

Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.

FDAJul 30, 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 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.: 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