Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Mar 29, 2017
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
FDA Devices Moderate Mar 29, 2017
ARTIS Q, Interventional Fluroscopic x-ray system
FDA Devices Moderate Mar 29, 2017
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to displ…
FDA Devices Moderate Mar 29, 2017
Mevatron M2/Primus Mid-Energy PRIMUS HI
FDA Devices Moderate Mar 22, 2017
Artis Q and Q.Zen fluoroscopic x-ray system
FDA Devices Moderate Mar 22, 2017
Artis Zee and Zeego fluoroscopic x-ray system
FDA Devices Moderate Mar 15, 2017
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerato…
FDA Devices Moderate Mar 15, 2017
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care …
FDA Devices Moderate Mar 15, 2017
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to del…
FDA Devices Moderate Mar 15, 2017
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to de…
FDA Devices Moderate Mar 15, 2017
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelera…
FDA Devices Moderate Mar 15, 2017
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care profes…
FDA Devices Moderate Mar 15, 2017
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health…
FDA Devices Moderate Feb 22, 2017
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin…
FDA Devices Moderate Feb 22, 2017
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin…
FDA Devices Moderate Feb 22, 2017
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelera…
FDA Devices Moderate Feb 22, 2017
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use o…
FDA Devices Moderate Feb 8, 2017
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exa…
FDA Devices Moderate Feb 8, 2017
Syngo.plaza, picture archiving and communications system.
FDA Devices Moderate Jan 18, 2017
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograph…
FDA Devices Moderate Jan 18, 2017
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomogra…
FDA Devices Moderate Jan 18, 2017
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …
FDA Devices Moderate Jan 18, 2017
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …
FDA Devices Moderate Jan 18, 2017
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …
FDA Devices Moderate Jan 18, 2017
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and …
FDA Devices Moderate Jan 18, 2017
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …
FDA Devices Moderate Jan 18, 2017
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT…
FDA Devices Moderate Jan 18, 2017
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …
FDA Devices Moderate Jan 4, 2017
SOMATOM Perspective, Computed tomography x-ray system
FDA Devices Moderate Dec 21, 2016
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-r…
FDA Devices Moderate Dec 14, 2016
SOMATOM Force, System x-ray, tomography, computed
FDA Devices Moderate Dec 7, 2016
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging s…
FDA Devices Moderate Nov 23, 2016
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cros…
FDA Devices Moderate Nov 23, 2016
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross…
FDA Devices Moderate Nov 23, 2016
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images …
FDA Devices Moderate Nov 23, 2016
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images …
FDA Devices Moderate Nov 23, 2016
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplan…
FDA Devices Moderate Nov 23, 2016
Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single an…
FDA Devices Moderate Nov 16, 2016
SOMATOM Definition AS system, x-ray, tomography, computed
FDA Devices Moderate Oct 19, 2016
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: plana…
FDA Devices Moderate Oct 12, 2016
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical pr…
FDA Devices Moderate Oct 5, 2016
Syngo.plaza, Picture Archiving and Communication System
FDA Devices Moderate Oct 5, 2016
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, process…
FDA Devices Moderate Oct 5, 2016
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of ca…
FDA Devices Moderate Oct 5, 2016
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray pho…
FDA Devices Moderate Sep 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, an…
FDA Devices Moderate Sep 21, 2016
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital me…
FDA Devices Moderate Sep 14, 2016
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the fol…
FDA Devices Moderate Aug 31, 2016
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
FDA Devices Moderate Aug 17, 2016