Siemens Medical Solutions USA, Inc
530 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate May 10, 2023
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic …
FDA Devices Moderate May 3, 2023
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
FDA Devices Moderate Apr 5, 2023
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
FDA Devices Moderate Mar 1, 2023
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
FDA Devices Moderate Mar 1, 2023
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
FDA Devices Moderate Mar 1, 2023
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
FDA Devices Moderate Mar 1, 2023
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
FDA Devices Moderate Mar 1, 2023
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
FDA Devices Moderate Feb 22, 2023
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
FDA Devices Moderate Feb 22, 2023
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
FDA Devices Moderate Feb 8, 2023
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego …
FDA Devices Moderate Feb 1, 2023
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Comput…
FDA Devices Moderate Jan 25, 2023
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
FDA Devices Moderate Jan 25, 2023
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
FDA Devices Moderate Jan 11, 2023
Programmable Diagnostic Computer
FDA Devices Moderate Dec 21, 2022
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear acc…
FDA Devices Moderate Sep 7, 2022
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Devices Low Aug 24, 2022
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis…
FDA Devices Moderate Jul 27, 2022
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, …
FDA Devices Moderate Jul 13, 2022
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Devices Moderate Jul 13, 2022
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
FDA Devices Moderate Jul 6, 2022
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
FDA Devices Moderate Jun 15, 2022
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Devices Moderate May 4, 2022
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
FDA Devices Moderate May 4, 2022
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upg…
FDA Devices Moderate May 4, 2022
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade …
FDA Devices Moderate Apr 27, 2022
Artis zee floor MN, Model Number 10094142
FDA Devices Moderate Apr 27, 2022
Artis Q ceiling, Model Number 10848281
FDA Devices Moderate Apr 27, 2022
Artis Q zeego, Model Number 10848283
FDA Devices Moderate Apr 27, 2022
Artis Q.zen floor, Model Number 10848353
FDA Devices Moderate Apr 27, 2022
Artis zee biplane, Model Number 10094141
FDA Devices Moderate Apr 27, 2022
Artis zee multi-purpose, Model Number 10094139
FDA Devices Moderate Apr 27, 2022
Artis zee biplane MN, Model Number 10094143
FDA Devices Moderate Apr 27, 2022
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All…
FDA Devices Moderate Apr 27, 2022
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging …
FDA Devices Moderate Apr 27, 2022
Artis Q floor, Model Number 10848280
FDA Devices Moderate Apr 27, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imagi…
FDA Devices Moderate Apr 27, 2022
Artis zee ceiling, Model Number 10094137
FDA Devices Moderate Mar 23, 2022
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the follow…
FDA Devices Moderate Feb 2, 2022
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
FDA Devices Moderate Feb 2, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Devices Moderate Feb 2, 2022
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Devices Moderate Jan 26, 2022
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # …
FDA Devices Moderate Jan 19, 2022
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Devices Moderate Jan 19, 2022
SOMATOM Definition AS-Computed tomography system Model 8098027
FDA Devices Moderate Jan 19, 2022
SOMATOM Definition Edge -Computed tomography system Model 10590000
FDA Devices Moderate Jan 19, 2022
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Devices Moderate Jan 5, 2022
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. M…
FDA Devices Moderate Dec 1, 2021
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…
FDA Devices Moderate Dec 1, 2021