Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jan 21, 2015
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
FDA Devices Moderate Jan 21, 2015
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmiss…
FDA Devices Moderate Jan 21, 2015
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single a…
FDA Devices Moderate Jan 21, 2015
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and bi…
FDA Devices Moderate Jan 14, 2015
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following tec…
FDA Devices Moderate Jan 14, 2015
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, stagi…
FDA Devices Moderate Jan 14, 2015
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, stagi…
FDA Devices Moderate Dec 24, 2014
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emis…
FDA Devices Moderate Dec 24, 2014
Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron …
FDA Devices Moderate Dec 24, 2014
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Posit…
FDA Devices Moderate Dec 17, 2014
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) inten…
FDA Devices Moderate Dec 10, 2014
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialize…
FDA Devices Moderate Oct 29, 2014
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and st…
FDA Devices Moderate Oct 29, 2014
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
FDA Devices Moderate Oct 29, 2014
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionucli…
FDA Devices Moderate Oct 8, 2014
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and f…
FDA Devices Moderate Oct 8, 2014
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. …
FDA Devices Moderate Oct 8, 2014
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (func…
FDA Devices Moderate Oct 8, 2014
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and t…
FDA Devices Moderate Oct 8, 2014
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise …
FDA Devices Moderate Oct 1, 2014
Artis zee and Artis zeego systems. x-ray, angiographic system
FDA Devices Moderate Oct 1, 2014
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abd…
FDA Devices Moderate Sep 24, 2014
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system…
FDA Devices Moderate Sep 17, 2014
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radi…
FDA Devices Moderate Sep 10, 2014
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applicat…
FDA Devices Moderate Jul 30, 2014
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, pro…
FDA Devices Moderate Jul 23, 2014
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the f…
FDA Devices Moderate Jul 9, 2014
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use …
FDA Devices Moderate Jul 9, 2014
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. …
FDA Devices Moderate Jul 2, 2014
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to …
FDA Devices Moderate Jul 2, 2014
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic…
FDA Devices Moderate Jun 11, 2014
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices…
FDA Devices Moderate Jun 11, 2014
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic s…
FDA Devices Moderate Jun 4, 2014
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
FDA Devices Moderate Jun 4, 2014
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, co…
FDA Devices Moderate May 21, 2014
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and man…
FDA Devices Moderate Apr 30, 2014
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiogra…
FDA Devices Moderate Apr 23, 2014
AXIOM Vertix MD Trauma systems radiographic X-ray
FDA Devices Moderate Apr 9, 2014
Artis Zee Angiographic x-ray systems.
FDA Devices Moderate Apr 2, 2014
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
FDA Devices Moderate Apr 2, 2014
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
FDA Devices Moderate Mar 26, 2014
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
FDA Devices Moderate Mar 5, 2014
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
FDA Devices Moderate Feb 12, 2014
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
FDA Devices Moderate Feb 5, 2014
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 …
FDA Devices Moderate Dec 11, 2013
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMR…
FDA Devices Moderate Dec 11, 2013
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the…
FDA Devices Moderate Dec 4, 2013
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluorosc…
FDA Devices Moderate Oct 30, 2013
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 …
FDA Devices Moderate Sep 4, 2013