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Siemens Medical Solutions USA, Inc

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 recall (Z-0119-2023)Siemens Medical Solutions USA, Inc2022-10-21
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Mod recall (Z-1645-2022)Siemens Medical Solutions USA, Inc2022-08-26
Artis pheno- Model No. 10849000 recall (Z-1646-2022)Siemens Medical Solutions USA, Inc2022-08-26
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 recall (Z-1647-2022)Siemens Medical Solutions USA, Inc2022-08-26
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 recall (Z-1294-2022)Siemens Medical Solutions USA, Inc2022-06-27
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 66481 recall (Z-1243-2022)Siemens Medical Solutions USA, Inc2022-06-06
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , recall (Z-1010-2022)Siemens Medical Solutions USA, Inc.2022-04-27
Artis zee floor, Model Number 10094135 recall (Z-0967-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zee ceiling, Model Number 10094137 recall (Z-0968-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zee multi-purpose, Model Number 10094139 recall (Z-0969-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zee biplane, Model Number 10094141 recall (Z-0970-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zee floor MN, Model Number 10094142 recall (Z-0971-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zee biplane MN, Model Number 10094143 recall (Z-0972-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis zeego, Model Number 10280959 recall (Z-0973-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q floor, Model Number 10848280 recall (Z-0974-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q ceiling, Model Number 10848281 recall (Z-0975-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q biplane, Model Number 10848282 recall (Z-0976-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q zeego, Model Number 10848283 recall (Z-0977-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q.zen floor, Model Number 10848353 recall (Z-0978-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q.zen ceiling, Model Number 10848354 recall (Z-0979-2022)Siemens Medical Solutions USA, Inc2022-04-21
Artis Q.zen biplane, Model Number 10848355 recall (Z-0980-2022)Siemens Medical Solutions USA, Inc2022-04-21
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 110076 recall (Z-0499-2022)Siemens Medical Solutions USA, Inc2022-01-14
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation recall (Z-2445-2021)Siemens Medical Solutions USA, Inc2021-09-10
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMAT recall (Z-2446-2021)Siemens Medical Solutions USA, Inc2021-09-10
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license recall (Z-2447-2021)Siemens Medical Solutions USA, Inc2021-09-10
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 664 recall (Z-1434-2021)Siemens Medical Solutions USA, Inc2021-04-19
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS recall (Z-0400-2021)Siemens Medical Solutions USA, Inc2020-11-04
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model recall (Z-3025-2020)Siemens Medical Solutions USA, Inc2020-09-28
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic recall (Z-2921-2020)Siemens Medical Solutions USA, Inc2020-08-28
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - recall (Z-2848-2020)Siemens Medical Solutions USA, Inc2020-08-22
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammog recall (Z-2388-2020)Siemens Medical Solutions USA, Inc2020-06-16
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Sp recall (Z-1957-2020)Siemens Medical Solutions USA, Inc2020-05-04
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios S recall (Z-1958-2020)Siemens Medical Solutions USA, Inc2020-05-04
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios recall (Z-1959-2020)Siemens Medical Solutions USA, Inc2020-05-04
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA recall (Z-2127-2020)Siemens Medical Solutions USA, Inc2020-05-04
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194 recall (Z-2128-2020)Siemens Medical Solutions USA, Inc2020-05-04
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Mo recall (Z-1495-2020)Siemens Medical Solutions USA, Inc2020-03-13
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.ze recall (Z-1496-2020)Siemens Medical Solutions USA, Inc2020-03-13
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Fl recall (Z-1497-2020)Siemens Medical Solutions USA, Inc2020-03-13
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. recall (Z-1501-2020)Siemens Medical Solutions USA, Inc2020-03-03
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging o recall (Z-0782-2020)Siemens Medical Solutions USA, Inc2020-01-07
Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the recall (Z-2195-2019)Siemens Medical Solutions USA, Inc2019-08-06
Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the recall (Z-2196-2019)Siemens Medical Solutions USA, Inc2019-08-06
Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the rad recall (Z-2197-2019)Siemens Medical Solutions USA, Inc2019-08-06
Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow recall (Z-2198-2019)Siemens Medical Solutions USA, Inc2019-08-06
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: T recall (Z-2248-2018)Siemens Medical Solutions USA, Inc.2018-06-08
Syngo.Via VB20A model 1049610 recall (Z-1778-2018)Siemens Medical Solutions USA, Inc2018-05-09
SOMATOM Emotion 6 (Model 10165888) recall (Z-2472-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Emotion 16 (10165977) recall (Z-2473-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Perspective (Model 10495568) recall (Z-2474-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Perspective 16 (Model 10891666) recall (Z-2475-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Scope ( Model 10967666) recall (Z-2476-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Scope Power (Model 10967888) recall (Z-2477-2018)Siemens Medical Solutions USA, Inc2018-03-30
SOMATOM Spirit(Model 10045692 ) recall (Z-2478-2018)Siemens Medical Solutions USA, Inc2018-03-30
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions U recall (Z-1200-2018)Siemens Medical Solutions USA, Inc.2018-03-26
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system d recall (Z-1148-2018)Siemens Medical Solutions USA, Inc2018-03-20
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Arti recall (Z-1150-2018)Siemens Medical Solutions USA, Inc2018-03-20
Syngo.via. Medical Device Software. Picture archiving and communications system. recall (Z-1303-2018)Siemens Medical Solutions USA, Inc2018-03-20
Artis zee, Angiographic x-ray system recall (Z-1824-2017)Siemens Medical Solutions USA, Inc2017-03-30
Syngo.x, Picture archiving and communication system Syngo via is a software solution inten recall (Z-1688-2017)Siemens Medical Solutions USA, Inc2017-03-27
Syngo.via, Picture archiving and communication system Syngo via is a software solution int recall (Z-1689-2017)Siemens Medical Solutions USA, Inc2017-03-27
ARTIS Q, Interventional Fluroscopic x-ray system recall (Z-1534-2017)Siemens Medical Solutions USA, Inc2017-03-19
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture A recall (Z-1533-2017)Siemens Medical Solutions USA, Inc2017-03-10
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to recall (Z-1422-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to recall (Z-1423-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are inten recall (Z-1424-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are recall (Z-1425-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT recall (Z-0992-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT recall (Z-0993-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow recall (Z-0994-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT recall (Z-0995-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT recall (Z-0996-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow recall (Z-0997-2017)Siemens Medical Solutions USA Inc.2017-01-10
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biogra recall (Z-0998-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biog recall (Z-0999-2017)Siemens Medical Solutions USA Inc.2017-01-10
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT recall (Z-1000-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph recall (Z-1001-2017)Siemens Medical Solutions USA Inc.2017-01-10
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mC recall (Z-1002-2017)Siemens Medical Solutions USA Inc.2017-01-10
SOMATOM Force, System x-ray, tomography, computed recall (Z-0692-2017)Siemens Medical Solutions USA, Inc2016-12-02
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 1043 recall (Z-0667-2017)Siemens Medical Solutions USA, Inc.2016-11-28
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedica recall (Z-0601-2017)Siemens Medical Solutions USA, Inc2016-11-17
Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family o recall (Z-0602-2017)Siemens Medical Solutions USA, Inc2016-11-17
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of de recall (Z-0603-2017)Siemens Medical Solutions USA, Inc2016-11-17
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash recall (Z-0604-2017)Siemens Medical Solutions USA, Inc2016-11-17
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS recall (Z-0605-2017)Siemens Medical Solutions USA, Inc2016-11-17
SOMATOM Definition AS system, x-ray, tomography, computed recall (Z-0373-2017)Siemens Medical Solutions USA, Inc2016-11-08
SOMATOM Definition Flash system, x-ray, tomography, computed recall (Z-0374-2017)Siemens Medical Solutions USA, Inc2016-11-08
Syngo.plaza, Picture Archiving and Communication System recall (Z-2891-2016)Siemens Medical Solutions USA, Inc2016-09-27
Syngo.plaza VB10A, Picture Archiving and Communication System recall (Z-2892-2016)Siemens Medical Solutions USA, Inc2016-09-27
Syngo.x picture archiving and communication system Syngo.x is a software solution intended recall (Z-2852-2016)Siemens Medical Solutions USA, Inc2016-09-21
Syngo.via picture archiving and communication system Syngo via is a software solution inte recall (Z-2853-2016)Siemens Medical Solutions USA, Inc2016-09-21
Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, p recall (Z-2793-2016)Siemens Medical Solutions USA, Inc2016-09-14
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, re recall (Z-2794-2016)Siemens Medical Solutions USA, Inc2016-09-14
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomograp recall (Z-2624-2016)Siemens Medical Solutions USA, Inc2016-08-23
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomog recall (Z-2625-2016)Siemens Medical Solutions USA, Inc2016-08-23
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomograp recall (Z-2626-2016)Siemens Medical Solutions USA, Inc2016-08-23
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, recall (Z-2088-2016)Siemens Medical Solutions USA, Inc2016-06-29
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are com recall (Z-2005-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems recall (Z-2006-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are recall (Z-2007-2016)Siemens Medical Solutions USA Inc.2016-06-21
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