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Siemens Medical Solutions USA, Inc

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). L recall (Z-2404-2011)Siemens Medical Solutions USA, Inc2011-06-02
syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo recall (Z-2293-2011)Siemens Medical Solutions, USA, Inc2011-05-25
ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 syste recall (Z-2243-2011)Siemens Medical Solutions USA, Inc2011-05-23
ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combi recall (Z-2216-2011)Siemens Medical Solutions USA, Inc2011-05-19
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize recall (Z-2190-2011)Siemens Medical Solutions USA, Inc2011-05-12
Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 103485 recall (Z-2147-2011)Siemens Medical Solutions USA, Inc.2011-05-06
Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-componen recall (Z-2150-2011)Siemens Medical Solutions USA, Inc.2011-05-06
LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Co recall (Z-2151-2011)Siemens Medical Solutions USA, Inc2011-05-06
4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound sy recall (Z-2149-2011)Siemens Medical Solutions USA, Inc.2011-05-05
ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemen recall (Z-2115-2011)Siemens Medical Solutions USA, Inc.2011-04-29
ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens recall (Z-2116-2011)Siemens Medical Solutions USA, Inc.2011-04-29
ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical recall (Z-2117-2011)Siemens Medical Solutions USA, Inc.2011-04-29
ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solu recall (Z-2118-2011)Siemens Medical Solutions USA, Inc.2011-04-29
Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (mode recall (Z-2061-2011)Siemens Medical Solutions USA, Inc.2011-04-25
Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model num recall (Z-2065-2011)Siemens Medical Solutions USA, Inc.2011-04-25
ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Busines recall (Z-2051-2011)Siemens Medical Solutions USA, Inc.2011-04-22
Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufacture recall (Z-2023-2011)Siemens Medical Solutions USA, Inc2011-04-19
MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging. recall (Z-2021-2011)Siemens Medical Solutions USA, Inc2011-04-18
Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelera recall (Z-2000-2011)Siemens Medical Solutions USA, Inc2011-04-15
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the recall (Z-1970-2011)Siemens Medical Solutions USA, Inc2011-04-13
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system recall (Z-1959-2011)Siemens Medical Solutions USA, Inc2011-04-12
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUS recall (Z-1961-2011)Siemens Medical Solutions USA, Inc.2011-04-12
8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model numbe recall (Z-1907-2011)Siemens Medical Solutions USA, Inc.2011-04-08
Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, V recall (Z-1900-2011)Siemens Medical Solutions USA, Inc.2011-04-06
TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: recall (Z-1884-2011)Siemens Medical Solutions USA, Inc.2011-04-04
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. recall (Z-1853-2011)Siemens Medical Solutions USA, Inc.2011-03-30
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imag recall (Z-1832-2011)Siemens Medical Solutions USA, Inc.2011-03-28
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation thera recall (Z-1834-2011)Siemens Medical Solutions USA, Inc2011-03-28
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLi recall (Z-1745-2011)Siemens Medical Solutions USA, Inc.2011-03-23
MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management recall (Z-1572-2011)Siemens Medical Solutions USA, Inc2011-03-07
Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist versio recall (Z-1523-2011)Siemens Medical Solutions USA, Inc2011-03-04
MAGNETOM Verio Nuclear magnetic resonance imaging recall (Z-1401-2011)Siemens Medical Solutions USA, Inc2011-02-23
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensifi recall (Z-1421-2011)Siemens Medical Solutions USA, Inc2011-02-23
V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac opti recall (Z-1392-2011)Siemens Medical Solutions USA, Inc.2011-02-22
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Th recall (Z-1064-2011)Siemens Medical Solutions USA, Inc2011-02-08
10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, recall (Z-1005-2011)Siemens Medical Solutions USA, Inc.2011-02-01
10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Inten recall (Z-1006-2011)Siemens Medical Solutions USA, Inc.2011-02-01
10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain Vi recall (Z-1007-2011)Siemens Medical Solutions USA, Inc.2011-02-01
Acuson Antares Ultrasound System Diagnostic Ultrasound system recall (Z-0896-2011)Siemens Medical Solutions USA, Inc.2011-01-12
4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens M recall (Z-0826-2011)Siemens Medical Solutions USA, Inc.2010-12-28
ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultras recall (Z-0827-2011)Siemens Medical Solutions USA, Inc.2010-12-28
Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager) recall (Z-0717-2011)Siemens Medical Solutions USA, Inc2010-12-17
Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system recall (Z-0718-2011)Siemens Medical Solutions USA, Inc2010-12-17
Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat recall (Z-0449-2011)Siemens Medical Solutions USA, Inc2010-11-24
Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile recall (Z-0171-2011)Siemens Medical Solutions USA, Inc2010-11-01
Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured recall (Z-0166-2011)Siemens Medical Solutions USA, Inc2010-10-28
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904 recall (Z-0144-2011)Siemens Medical Solutions USA, Inc2010-10-26
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. recall (Z-2233-2010)Siemens Medical Solutions USA, Inc2010-08-16
SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imag recall (Z-2222-2010)Siemens Medical Solutions USA, Inc2010-08-13
Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS. recall (Z-1892-2010)Siemens Medical Solutions USA, Inc2010-06-24
Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malver recall (Z-1732-2010)Siemens Medical Solutions USA, Inc2010-05-28
Syngo Imaging XS model number 10496279 The intended use: image processing radiological recall (Z-1423-2010)Siemens Medical Solutions USA, Inc2010-04-20
Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 70086 recall (Z-1312-2010)Siemens Medical Solutions USA, Inc2010-04-08
Axiom Artis Systems operating with A100 Generator recall (Z-1237-2010)Siemens Medical Solutions USA, Inc2010-04-05
Axiom Iconos R200 X-Ray recall (Z-1213-2010)Siemens Medical Solutions USA, Inc2010-03-27
Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical recall (Z-0583-2010)Siemens Medical Solutions USA, Inc.2009-12-29
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomograp recall (Z-0584-2010)Siemens Medical Solutions USA, Inc.2009-12-29
Axiom Artis MP, Model number 5904466 angiographic x-ray systems recall (Z-0483-2010)Siemens Medical Solutions USA, Inc2009-12-03
Axiom Artis dMP, Model number 7555365 angiographic x-ray systems recall (Z-0484-2010)Siemens Medical Solutions USA, Inc2009-12-03
Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems recall (Z-0485-2010)Siemens Medical Solutions USA, Inc2009-12-03
Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression. recall (Z-0270-2010)Siemens Medical Solutions USA, Inc2009-11-16
Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression recall (Z-0271-2010)Siemens Medical Solutions USA, Inc2009-11-16
Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Ind recall (Z-0189-2010)Siemens Medical Solutions USA, Inc2009-11-12
Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment. recall (Z-0162-2010)Siemens Medical Solutions USA Inc.2009-11-10
Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging Equipment. recall (Z-0163-2010)Siemens Medical Solutions USA Inc.2009-11-10
Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment. recall (Z-0164-2010)Siemens Medical Solutions USA Inc.2009-11-10
Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an An recall (Z-0166-2010)Siemens Medical Solutions USA, Inc2009-11-10
Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an An recall (Z-0167-2010)Siemens Medical Solutions USA, Inc2009-11-10
Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license recall (Z-0174-2010)Siemens Medical Solutions USA, Inc2009-11-10
Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapi recall (Z-0121-2010)Siemens Medical Solutions USA, Inc2009-11-05
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number recall (Z-1888-2009)Siemens Medical Solutions USA, Inc2009-09-24
Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical recall (Z-1676-2009)Siemens Medical Solutions USA, Inc.2009-08-04
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomograp recall (Z-1677-2009)Siemens Medical Solutions USA, Inc.2009-08-04
Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X recall (Z-1675-2009)Siemens Medical Solutions USA, Inc2009-07-30
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission recall (Z-1648-2009)Siemens Medical Solutions USA, Inc.2009-07-07
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Comp recall (Z-1649-2009)Siemens Medical Solutions USA, Inc.2009-07-07
syngo Imaging Version V31 Picture Archiving and Communication System, model number 1001406 recall (Z-1650-2009)Siemens Medical Solutions USA, Inc2009-07-07
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicato recall (Z-1505-2009)Siemens Medical Solutions USA, Inc.2009-06-24
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1437-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1438-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1439-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1440-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1441-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1442-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1443-2009)Siemens Medical Solutions USA, Inc2009-06-16
Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system recall (Z-1318-2009)Siemens Medical Solutions USA, Inc2009-06-01
Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900 recall (Z-1233-2009)Siemens Medical Solutions USA, Inc2009-05-07
AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as ra recall (Z-1253-2009)Siemens Medical Solutions USA, Inc2009-05-06
AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as ra recall (Z-1254-2009)Siemens Medical Solutions USA, Inc2009-05-06
syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063 recall (Z-1235-2009)Siemens Medical Solutions USA, Inc2009-04-28
syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS conn recall (Z-1266-2009)Siemens Medical Solutions USA, Inc2009-04-28
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manuf recall (Z-0949-2009)Siemens Medical Solutions USA, Inc2009-01-30
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 12 recall (Z-0927-2009)Siemens Medical Solutions USA, Inc2009-01-29
Somatom Definition AS, Model number 8098027. Computed tomography x-ray system recall (Z-0929-2009)Siemens Medical Solutions USA, Inc2009-01-23
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Ve recall (Z-0857-2009)Siemens Medical Solutions USA, Inc2009-01-14
Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT op recall (Z-0646-2009)Siemens Medical Solutions USA, Inc2009-01-13
CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT wor recall (Z-0647-2009)Siemens Medical Solutions USA, Inc2009-01-08
Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-r recall (Z-0320-2009)Siemens Medical Solutions USA, Inc2009-01-05
Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-r recall (Z-0321-2009)Siemens Medical Solutions USA, Inc2009-01-05
Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicat recall (Z-0543-2009)Siemens Medical Solutions, USA, Inc2009-01-02
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