Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jan 27, 2016
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following te…
FDA Devices Moderate Dec 30, 2015
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
FDA Devices Moderate Dec 30, 2015
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
FDA Devices Moderate Dec 2, 2015
Syngo Imaging VB36D_HF02. Radiological image processing system.
FDA Devices Moderate Nov 18, 2015
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
FDA Devices Moderate Nov 11, 2015
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ,…
FDA Devices Moderate Nov 4, 2015
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to d…
FDA Devices Moderate Oct 14, 2015
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
FDA Devices Moderate Oct 14, 2015
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
FDA Devices Moderate Oct 14, 2015
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the s…
FDA Devices Moderate Sep 30, 2015
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Prod…
FDA Devices Moderate Sep 23, 2015
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is in…
FDA Devices Moderate Sep 9, 2015
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intend…
FDA Devices Moderate Aug 26, 2015
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, …
FDA Devices Moderate Aug 26, 2015
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed …
FDA Devices Moderate Aug 26, 2015
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera syst…
FDA Devices Moderate Aug 12, 2015
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including…
FDA Devices Moderate Aug 12, 2015
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
FDA Devices Moderate Aug 12, 2015
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not …
FDA Devices Moderate Aug 12, 2015
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
FDA Devices Moderate Aug 12, 2015
Biograph mCT S(64)-4R, Model Number 10248672
FDA Devices Moderate Aug 12, 2015
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
FDA Devices Moderate Aug 12, 2015
Biograph mCT S(40)-4R, Model Number 10248671
FDA Devices Moderate Aug 12, 2015
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
FDA Devices Moderate Aug 5, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2…
FDA Devices Moderate Aug 5, 2015
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000…
FDA Devices Moderate Jul 8, 2015
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ult…
FDA Devices Moderate Jul 8, 2015
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
FDA Devices Moderate Jul 8, 2015
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,…
FDA Devices Moderate Jul 8, 2015
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane …
FDA Devices Moderate Jun 10, 2015
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient adm…
FDA Devices Moderate Jun 3, 2015
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures o…
FDA Devices Moderate Jun 3, 2015
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray trans…
FDA Devices Moderate Jun 3, 2015
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat…
FDA Devices Moderate Jun 3, 2015
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray tran…
FDA Devices Moderate Jun 3, 2015
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray tra…
FDA Devices Moderate May 13, 2015
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray…
FDA Devices Moderate May 13, 2015
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for…
FDA Devices Moderate Apr 8, 2015
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and arch…
FDA Devices Moderate Apr 1, 2015
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produc…
FDA Devices Moderate Mar 25, 2015
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all availa…
FDA Devices Moderate Mar 25, 2015
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniq…
FDA Devices Moderate Mar 25, 2015
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to d…
FDA Devices Moderate Mar 25, 2015
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniqu…
FDA Devices Moderate Mar 18, 2015
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended …
FDA Devices Moderate Feb 25, 2015
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obes…
FDA Devices Moderate Feb 18, 2015
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - …
FDA Devices Moderate Feb 11, 2015
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following ap…
FDA Devices Moderate Feb 4, 2015
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photo…
FDA Devices Moderate Jan 28, 2015