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Siemens Medical Solutions USA, Inc

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are recall (Z-2008-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint sys recall (Z-2009-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint s recall (Z-2010-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint sy recall (Z-2011-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are recall (Z-2012-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are recall (Z-2013-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems recall (Z-2014-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint recall (Z-2015-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint s recall (Z-2016-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoi recall (Z-2017-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint syste recall (Z-2018-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint syste recall (Z-2019-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems a recall (Z-2020-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems a recall (Z-2021-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems a recall (Z-2022-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems a recall (Z-2023-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems a recall (Z-2024-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems a recall (Z-2025-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems recall (Z-2026-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems recall (Z-2027-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems a recall (Z-2028-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are recall (Z-2029-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are recall (Z-2030-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are recall (Z-2031-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are recall (Z-2032-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are recall (Z-2033-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are com recall (Z-2034-2016)Siemens Medical Solutions USA Inc.2016-06-21
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TrueP recall (Z-2035-2016)Siemens Medical Solutions USA Inc.2016-06-21
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint recall (Z-2036-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are recall (Z-2037-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT recall (Z-1997-2016)Siemens Medical Solutions USA Inc.2016-06-15
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT sy recall (Z-1998-2016)Siemens Medical Solutions USA Inc.2016-06-15
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT recall (Z-1999-2016)Siemens Medical Solutions USA Inc.2016-06-15
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT recall (Z-2000-2016)Siemens Medical Solutions USA Inc.2016-06-15
Syngo Dynamics; Kinetdx Picture Archiving and Communications System recall (Z-1601-2016)Siemens Medical Solutions USA, Inc2016-05-04
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers recall (Z-1598-2016)Siemens Medical Solutions USA, Inc2016-05-03
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sec recall (Z-1558-2016)Siemens Medical Solutions USA, Inc2016-04-22
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Comput recall (Z-1518-2016)Siemens Medical Solutions USA, Inc2016-04-19
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Com recall (Z-1519-2016)Siemens Medical Solutions USA, Inc2016-04-19
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. recall (Z-1520-2016)Siemens Medical Solutions USA, Inc2016-04-19
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM De recall (Z-1521-2016)Siemens Medical Solutions USA, Inc2016-04-19
SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images o recall (Z-1350-2016)Siemens Medical Solutions USA, Inc2016-04-08
A Picture Archiving and Communication System (PACS) intended to display, process, read, re recall (Z-1349-2016)Siemens Medical Solutions USA, Inc2016-04-07
Cios Alpha, mobile X-ray system recall (Z-1278-2016)Siemens Medical Solutions USA, Inc2016-03-31
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q. recall (Z-1283-2016)Siemens Medical Solutions USA, Inc2016-03-31
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q. recall (Z-1284-2016)Siemens Medical Solutions USA, Inc2016-03-31
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Arti recall (Z-1299-2016)Siemens Medical Solutions USA, Inc2016-03-31
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-v recall (Z-1232-2016)Siemens Medical Solutions USA, Inc2016-03-23
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to di recall (Z-0862-2016)Siemens Medical Solutions USA, Inc2016-02-23
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended f recall (Z-0826-2016)Siemens Medical Solutions USA, Inc2016-02-19
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of recall (Z-0687-2016)Siemens Medical Solutions USA, Inc.2016-01-21
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. recall (Z-0597-2016)Siemens Medical Solutions USA, Inc2016-01-06
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional F recall (Z-0481-2016)Siemens Medical Solutions USA, Inc2015-12-24
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). recall (Z-0467-2016)Siemens Medical Solutions USA, Inc2015-12-22
Syngo Imaging VB36D_HF02. Radiological image processing system. recall (Z-0319-2016)Siemens Medical Solutions USA, Inc2015-11-20
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or im recall (Z-0208-2016)Siemens Medical Solutions USA, Inc.2015-11-04
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability t recall (Z-0182-2016)Siemens Medical Solutions USA, Inc.2015-10-30
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, M recall (Z-0168-2016)Siemens Medical Solutions USA, Inc2015-10-27
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits lo recall (Z-0106-2016)Siemens Medical Solutions USA, Inc2015-10-06
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-se recall (Z-0107-2016)Siemens Medical Solutions USA, Inc2015-10-06
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by compute recall (Z-0019-2016)Siemens Medical Solutions USA, Inc2015-10-05
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by comput recall (Z-0020-2016)Siemens Medical Solutions USA, Inc2015-10-05
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer recall (Z-0021-2016)Siemens Medical Solutions USA, Inc2015-10-05
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, S recall (Z-2812-2015)Siemens Medical Solutions USA, Inc2015-09-24
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Pr recall (Z-2783-2015)Siemens Medical Solutions USA, Inc.2015-09-17
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a P recall (Z-2719-2015)Siemens Medical Solutions USA, Inc2015-09-02
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- d recall (Z-2435-2015)Siemens Medical Solutions USA, Inc.2015-08-20
Siemens Symbia T Series, a radiological imaging system that is a combination of a single p recall (Z-2436-2015)Siemens Medical Solutions USA, Inc.2015-08-20
Siemens Intevo Series system, a radiological imaging system that is a combination of a sin recall (Z-2437-2015)Siemens Medical Solutions USA, Inc.2015-08-20
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane d recall (Z-2404-2015)Siemens Medical Solutions USA, Inc2015-08-18
Biograph mCT S(40)-4R, Model Number 10248671 recall (Z-2331-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph mCT S(64)-4R, Model Number 10248672 recall (Z-2332-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph mCT X-4R, Model Number 10248670 recall (Z-2333-2015)Siemens Medical Solutions USA Inc.2015-08-05
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 recall (Z-2334-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph mCT Flow Edge-4R, Model Number 10528955 recall (Z-2335-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 recall (Z-2336-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 recall (Z-2337-2015)Siemens Medical Solutions USA Inc.2015-08-05
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 recall (Z-2338-2015)Siemens Medical Solutions USA Inc.2015-08-05
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane recall (Z-2340-2015)Siemens Medical Solutions USA, Inc2015-08-05
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic recall (Z-2341-2015)Siemens Medical Solutions USA, Inc2015-08-05
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagno recall (Z-2342-2015)Siemens Medical Solutions USA, Inc2015-08-05
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6 recall (Z-2344-2015)Siemens Medical Solutions USA, Inc.2015-08-05
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model n recall (Z-2321-2015)Siemens Medical Solutions USA, Inc.2015-07-30
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3 recall (Z-2314-2015)Siemens Medical Solutions USA, Inc.2015-07-29
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of t recall (Z-1958-2015)Siemens Medical Solutions USA, Inc2015-07-02
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the St recall (Z-1959-2015)Siemens Medical Solutions USA, Inc.2015-07-02
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communicatio recall (Z-1972-2015)Siemens Medical Solutions USA, Inc2015-07-02
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction recall (Z-1933-2015)Siemens Medical Solutions USA, Inc2015-06-27
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction o recall (Z-1934-2015)Siemens Medical Solutions USA, Inc2015-06-27
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated ang recall (Z-1846-2015)Siemens Medical Solutions USA, Inc2015-06-25
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, recall (Z-1705-2015)Siemens Medical Solutions USA, Inc2015-06-03
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology infor recall (Z-1704-2015)Siemens Medical Solutions USA, Inc2015-06-02
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. recall (Z-1667-2015)Siemens Medical Solutions USA, Inc2015-05-23
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and recall (Z-1668-2015)Siemens Medical Solutions USA, Inc2015-05-23
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic st recall (Z-1669-2015)Siemens Medical Solutions USA, Inc2015-05-23
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily fo recall (Z-1670-2015)Siemens Medical Solutions USA, Inc2015-05-23
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional i recall (Z-1644-2015)Siemens Medical Solutions USA, Inc2015-05-22
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional recall (Z-1645-2015)Siemens Medical Solutions USA, Inc2015-05-22
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional recall (Z-1646-2015)Siemens Medical Solutions USA, Inc2015-05-22
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 1043381 recall (Z-1584-2015)Siemens Medical Solutions USA, Inc.2015-05-06
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