Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate May 23, 2018
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
FDA Devices Moderate May 23, 2018
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
FDA Devices Moderate May 23, 2018
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
FDA Devices Moderate May 16, 2018
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended…
FDA Devices Moderate May 16, 2018
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate…
FDA Devices Moderate May 16, 2018
Syngo.Via VB20A model 1049610
FDA Devices Moderate May 9, 2018
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
FDA Devices Moderate May 9, 2018
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate May 9, 2018
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Devices Moderate Apr 25, 2018
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therape…
FDA Devices Moderate Apr 25, 2018
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray…
FDA Devices Moderate Apr 25, 2018
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for…
FDA Devices Moderate Apr 4, 2018
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone dev…
FDA Devices Moderate Mar 28, 2018
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional pro…
FDA Devices Moderate Mar 28, 2018
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems develope…
FDA Devices Moderate Mar 7, 2018
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 772…
FDA Devices Moderate Mar 7, 2018
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
FDA Devices Moderate Mar 7, 2018
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional…
FDA Devices Moderate Mar 7, 2018
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
FDA Devices Moderate Mar 7, 2018
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectiona…
FDA Devices Moderate Feb 14, 2018
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagno…
FDA Devices Moderate Feb 14, 2018
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communicatio…
FDA Devices Moderate Feb 7, 2018
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza…
FDA Devices Moderate Jan 31, 2018
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, commu…
FDA Devices Moderate Nov 29, 2017
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS…
FDA Devices Moderate Nov 22, 2017
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, us…
FDA Devices Moderate Nov 22, 2017
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, usi…
FDA Devices Moderate Nov 1, 2017
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo mod…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Sep 6, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed fo…
FDA Devices Moderate Jul 12, 2017
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
FDA Devices Moderate May 31, 2017
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac cathe…
FDA Devices Moderate May 3, 2017
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 …
FDA Devices Moderate Apr 26, 2017
Artis zee, Angiographic x-ray system
FDA Devices Moderate Apr 19, 2017
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
FDA Devices Moderate Apr 5, 2017
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, a…
FDA Devices Moderate Mar 29, 2017