Home / Brands / Siemens Medical Solutions USA
Siemens Medical Solutions USA Recalls
796 recalls on record · August 1, 2012 to July 8, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography s
Hazard: Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography
Hazard: Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
January 4, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Perspective, Computed tomography x-ray system
Hazard: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
January 4, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Scope Power, Computed tomography x-ray system
Hazard: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
January 4, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Scope, Computed tomography x-ray system
Hazard: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
December 21, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by c
Hazard: Software update that provides software and firmware bug-fixes to improve system performance
December 21, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by
Hazard: Software update that provides software and firmware bug-fixes to improve system performance
December 21, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by com
Hazard: Software update that provides software and firmware bug-fixes to improve system performance
December 14, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Force, System x-ray, tomography, computed
Hazard: Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
December 7, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSO
Hazard: Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems
Hazard: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems
Hazard: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems ar
Hazard: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to pr
Hazard: A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to pr
Hazard: A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography syste
Hazard: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography sy
Hazard: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
November 23, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems de
Hazard: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
November 16, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash system, x-ray, tomography, computed
Hazard: Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
November 16, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS system, x-ray, tomography, computed
Hazard: Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
October 19, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body
Hazard: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
October 19, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using th
Hazard: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
October 12, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ys
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 12, 2016Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics,
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.