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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
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Cardiac Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation...
Medical Devices·18 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to d...
Medical Devices·18 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray r...
Medical Devices·7 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6 (Model 10165888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective 16 (Model 10891666)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective (Model 10495568)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Scope Power (Model 10967888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Spirit(Model 10045692 )
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Diagnostic Devices·42 affected·Jan 26, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interv...
Cardiac Devices·16 affected·Jan 12, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a st...
Medical Devices·165 affected·Jan 10, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography syst...
Diagnostic Devices·22 affected·Jan 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Diagnostic Devices·1,385 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Diagnostic Devices·134 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Diagnostic Devices·238 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body ...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body o...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cro...
Medical Devices·6 affected·Oct 2, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 478...
Medical Devices·1,557 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Medical Devices·510 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Sy...
Medical Devices·16 affected·Sep 18, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and bi...
Diagnostic Devices·265 affected·Aug 24, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and ...
Medical Devices·76 affected·Aug 23, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 ...
Medical Devices·47 affected·Aug 18, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, r...
Medical Devices·36 affected·Jul 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7...
Medical Devices·0 affected·Jun 6, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication ...
Medical Devices·2 affected·May 22, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic c...
Cardiac Devices·4,095 affected·Apr 12, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer...
Cardiac Devices·2,045 affected·Mar 30, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee, Angiographic x-ray system
Medical Devices·3 affected·Mar 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, comm...
Medical Devices·104 affected·Mar 6, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q and Q.Zen fluoroscopic x-ray system
Medical Devices·2,158 affected·Feb 27, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q, Interventional Fluroscopic x-ray system
Medical Devices·264 affected·Feb 22, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained ...
Medical Devices·9 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) inten...
Medical Devices·13 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health...
Medical Devices·18 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately tr...
Medical Devices·4 affected·Feb 20, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Avant-garde
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS f...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS f...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linea...
Medical Devices·35 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The in...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator syste...
Medical Devices·35 affected·Jan 25, 2017