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All Recalls

Every Siemens Medical Solutions Usa, Inc Recall

Sorted by most recent. Click any recall for full details.

509 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
Medical Devices·3 affected·Oct 28, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Medical Devices·15 affected·Sep 24, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON ...
Cardiac Devices·4 affected·Sep 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging ...
Cardiac Devices·2,039 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Medical Devices·21 affected·Aug 18, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fro...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from ...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of ca...
Medical Devices·26 affected·Aug 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging syste...
Diagnostic Devices·1,183 affected·Jul 31, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT)...
Medical Devices·185 affected·Jul 31, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-4R, Model Number 10248672
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
Medical Devices·2 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-4R, Model Number 10248671
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (...
Medical Devices·37 affected·Jul 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures...
Diagnostic Devices·586 affected·Jun 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedur...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the bo...
Medical Devices·32,296 affected·Jun 26, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10...
Cardiac Devices·1,789 affected·Jun 25, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 104...
Cardiac Devices·629 affected·Jun 25, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, r...
Medical Devices·5 affected·Jun 11, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same ...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: Th...
Cardiac Devices·573 affected·May 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for...
Medical Devices·131 affected·May 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended...
Medical Devices·158 affected·May 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction o...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction ...
Medical Devices·75 affected·Apr 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisit...
Medical Devices·43 affected·Apr 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic...
Diagnostic Devices·133 affected·Apr 13, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital...
Medical Devices·133 affected·Apr 13, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD)...
Diagnostic Devices·132 affected·Mar 9, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, st...
Medical Devices·4 affected·Feb 18, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: T...
Medical Devices·12 affected·Feb 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON an...
Medical Devices·87 affected·Jan 21, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediat...
Cardiac Devices·1 affected·Jan 16, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the ...
Cardiac Devices·230 affected·Jan 12, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and...
Medical Devices·24 affected·Jan 12, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver...
Medical Devices·3 affected·Jan 2, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic syst...
Diagnostic Devices·11 affected·Dec 15, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-r...
Medical Devices·7 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed ...
Cardiac Devices·50 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator sy...
Medical Devices·3 affected·Nov 19, 2014
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and P...
Medical Devices·8 affected·Nov 13, 2014