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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
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·3 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional proced...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Diagnostic Devices·12 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Diagnostic Devices·72 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Diagnostic Devices·23 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Medical Devices·298 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Medical Devices·665 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Medical Devices·232 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom sys...
Medical Devices·31 affected·Aug 18, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.T...
Medical Devices·44 affected·Aug 16, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q flo...
Diagnostic Devices·70 affected·Jun 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Diagnostic Devices·116 affected·May 27, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures i...
Diagnostic Devices·3,320 affected·Mar 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Medical Devices·772 affected·Mar 26, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a...
Diagnostic Devices·133 affected·Mar 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull...
Medical Devices·12 affected·Mar 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedur...
Diagnostic Devices·29 affected·Feb 26, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequ...
Diagnostic Devices·1,172 affected·Feb 4, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supportin...
Surgical Devices·37 affected·Jan 27, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for ...
Diagnostic Devices·41 affected·Dec 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Medical Devices·5,602 affected·Nov 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Medical Devices·3,044 affected·Nov 24, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems de...
Diagnostic Devices·100 affected·Sep 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological application...
Medical Devices·6 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applica...
Medical Devices·281 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionucl...
Medical Devices·412 affected·Aug 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ra...
Medical Devices·329 affected·Jul 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic...
Cardiac Devices·110 affected·Jul 24, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin...
Medical Devices·282 affected·Jul 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Cardiac Devices·0 affected·May 22, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies a...
Diagnostic Devices·230 affected·May 7, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 1084828...
Diagnostic Devices·15 affected·Apr 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray Syste...
Medical Devices·5 affected·Apr 23, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to pro...
Medical Devices·16 affected·Apr 20, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to prov...
Medical Devices·4 affected·Apr 20, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Medical Devices·20 affected·Apr 17, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposu...
Medical Devices·314 affected·Apr 6, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 ...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Syst...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: A...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 1...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Medical Devices·81 affected·Feb 10, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by conv...
Medical Devices·194 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visua...
Medical Devices·512 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ys...
Medical Devices·507 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by conv...
Medical Devices·477 affected·Jan 8, 2020