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Siemens Medical Solutions Usa, Inc Recalls
509 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Siemens Medical Solutions Usa, Inc.
509Total Recalls
19Critical
254,569Units Affected
Mar 12, 2026Most Recent
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 pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Medical Devices141 affectedFeb 2, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane...
Diagnostic Devices141 affectedFeb 2, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
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...
Medical Devices6 affectedJan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Medical Devices4 affectedJan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the followin...
Medical Devices29 affectedDec 22, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Diagnostic Devices2 affectedDec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Diagnostic Devices28 affectedDec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Diagnostic Devices7 affectedDec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Diagnostic Devices4 affectedDec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Diagnostic Devices1 affectedDec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Medical Devices550 affectedDec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 ...
Medical Devices609 affectedDec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Medical Devices886 affectedDec 9, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max (VE10, VF10, VF11)
Medical Devices704 affectedNov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF Max (VE10, VF10, VF11)
Medical Devices704 affectedNov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Programmable Diagnostic Computer
Diagnostic Devices2,213 affectedNov 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family o...
Medical Devices8 affectedNov 9, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Medical Devices1,389 affectedAug 10, 2022
RecallFDA
Siemens Medical Solutions Usa, Inc
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; ...
Cardiac Devices399 affectedJul 12, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiolo...
Cardiac Devices2 affectedJun 15, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Medical Devices136 affectedJun 10, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Medical Devices233 affectedMay 24, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Medical Devices195 affectedMay 20, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Medical Devices31 affectedMar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SO...
Medical Devices547 affectedMar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 softwa...
Medical Devices1 affectedMar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software af...
Medical Devices1 affectedMar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnos...
Diagnostic Devices35 affectedFeb 25, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diag...
Diagnostic Devices94 affectedFeb 25, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor MN, Model Number 10094142
Medical Devices24 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q ceiling, Model Number 10848281
Medical Devices418 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q zeego, Model Number 10848283
Medical Devices38 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen floor, Model Number 10848353
Medical Devices33 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane, Model Number 10094141
Medical Devices373 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee multi-purpose, Model Number 10094139
Medical Devices277 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane MN, Model Number 10094143
Medical Devices7 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor, Model Number 10848280
Medical Devices80 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling, Model Number 10094137
Medical Devices709 affectedFeb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended fo...
Diagnostic Devices2,846 affectedJan 19, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment o...
Medical Devices13 affectedDec 9, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo,...
Cardiac Devices1,047 affectedNov 23, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Edge Plus-Computed tomography system Model 1026700
Medical Devices80 affectedNov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS-Computed tomography system Model 8098027
Medical Devices794 affectedNov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
Medical Devices0 affectedNov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence -Computed tomography systems Model 10590100
Medical Devices108 affectedNov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedu...
Diagnostic Devices15 affectedOct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices8 affectedOct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices15 affectedOct 20, 2021