Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
FDA Devices Moderate Dec 1, 2021
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
FDA Devices Moderate Dec 1, 2021
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number…
FDA Devices Moderate Dec 1, 2021
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure …
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
FDA Devices Moderate Dec 1, 2021
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model …
FDA Devices Moderate Dec 1, 2021
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
FDA Devices Moderate Dec 1, 2021
SOMATOM Force with software syngo.CT VB20 Model #10742326
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
FDA Devices Moderate Sep 29, 2021
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMAT…
FDA Devices Moderate Sep 22, 2021
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.Top SOMATOM…
FDA Devices Moderate Sep 22, 2021
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Devices Moderate Sep 8, 2021
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 …
FDA Devices Moderate Jul 14, 2021
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
FDA Devices Moderate Jun 9, 2021
Multitom RAX with software version VF10
FDA Devices Moderate May 5, 2021
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, bu…
FDA Devices Moderate May 5, 2021
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of d…
FDA Devices Moderate May 5, 2021
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
FDA Devices Moderate Apr 14, 2021
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abd…
FDA Devices Moderate Apr 7, 2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnost…
FDA Devices Moderate Mar 31, 2021
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…
FDA Devices Moderate Mar 10, 2021
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynami…
FDA Devices Moderate Mar 3, 2021
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and b…
FDA Devices Moderate Jan 20, 2021
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Devices Moderate Jan 20, 2021
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
FDA Devices Moderate Jan 20, 2021
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functiona…
FDA Devices Moderate Jan 20, 2021
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (funct…
FDA Devices Moderate Nov 11, 2020
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for …
FDA Devices Moderate Oct 14, 2020
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
FDA Devices Moderate Sep 9, 2020
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the …
FDA Devices Moderate Sep 9, 2020
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheteriza…
FDA Devices Moderate Sep 2, 2020
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of…
FDA Devices Moderate Sep 2, 2020
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, usin…
FDA Devices Moderate Sep 2, 2020
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobil…
FDA Devices Moderate Sep 2, 2020
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging o…
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomi…
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
FDA Devices Moderate Jun 24, 2020
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual ener…
FDA Devices Moderate Jun 17, 2020
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q…
FDA Devices Moderate Jun 10, 2020
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Num…
FDA Devices Moderate Jun 3, 2020
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
FDA Devices Moderate May 20, 2020
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray i…
FDA Devices Moderate May 20, 2020
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray im…
FDA Devices Moderate May 13, 2020
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without …
FDA Devices Moderate Apr 15, 2020
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #094015…
FDA Devices Moderate Apr 15, 2020
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control …
FDA Devices Moderate Mar 25, 2020
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a fa…
FDA Devices Moderate Mar 25, 2020
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Pro…
FDA Devices Moderate Mar 25, 2020