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Siemens Medical Solutions USA Recalls

796 recalls on record · August 1, 2012 to July 8, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

October 12, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospi
Hazard: Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
October 5, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.plaza VB10A, Picture Archiving and Communication System
Hazard: Software upgrade to eliminate several issues
October 5, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.plaza, Picture Archiving and Communication System
Hazard: Software upgrade to eliminate several issues
October 5, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use
Hazard: Software patch installation to address several safety issues.
October 5, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation fo
Hazard: Software patch installation to address several safety issues.
October 5, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator sy
Hazard: Software patch installation to address several safety issues.
September 28, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing
Hazard: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
September 28, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, ma
Hazard: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
September 21, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute,
Hazard: Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
September 21, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communic
Hazard: Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
September 14, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the
Hazard: "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."
August 31, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Hazard: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
August 31, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Hazard: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
August 31, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Hazard: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
August 17, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee /
Hazard: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
August 17, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedi
Hazard: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
August 17, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen a
Hazard: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
August 17, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139,
Hazard: Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
July 27, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipula
Hazard: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
July 6, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography im
Hazard: Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
July 6, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Hazard: Software error in previous software versions in which two references for the same image may exist in the database.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomogr
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
June 29, 2016Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed To
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.