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Siemens Medical Solutions USA, Inc

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Mobiletta Mira Mobile X-ray System recall (Z-1875-2013)Siemens Medical Solutions USA, Inc2013-08-05
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system recall (Z-1848-2013)Siemens Medical Solutions USA, Inc2013-08-01
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system recall (Z-1859-2013)Siemens Medical Solutions USA, Inc2013-08-01
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device i recall (Z-1795-2013)Siemens Medical Solutions USA, Inc2013-07-24
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have P recall (Z-1782-2013)Siemens Medical Solutions USA, Inc2013-07-22
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Ang recall (Z-1750-2013)Siemens Medical Solutions USA, Inc2013-07-17
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography recall (Z-1694-2013)Siemens Medical Solutions USA, Inc2013-07-11
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Syst recall (Z-1663-2013)Siemens Medical Solutions USA, Inc2013-07-03
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS recall (Z-1562-2013)Siemens Medical Solutions USA, Inc2013-06-21
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therap recall (Z-1182-2013)Siemens Medical Solutions USA, Inc2013-04-26
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The recall (Z-1105-2013)Siemens Medical Solutions USA, Inc2013-04-12
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, recall (Z-1097-2013)Siemens Medical Solutions USA, Inc2013-04-11
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded recall (Z-1077-2013)Siemens Medical Solutions USA, Inc2013-04-10
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains vers recall (Z-1081-2013)Siemens Medical Solutions USA, Inc.2013-04-10
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1036-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1037-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1038-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1039-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1040-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1041-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1042-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1043-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1044-2013)Siemens Medical Solutions USA, Inc2013-04-02
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Ang recall (Z-0997-2013)Siemens Medical Solutions USA, Inc2013-03-26
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction recall (Z-0992-2013)Siemens Medical Solutions USA, Inc2013-03-25
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and recall (Z-0948-2013)Siemens Medical Solutions USA, Inc2013-03-14
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by recall (Z-0930-2013)Siemens Medical Solutions USA, Inc.2013-03-09
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 081628 recall (Z-0907-2013)Siemens Medical Solutions USA, Inc2013-03-05
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted su recall (Z-0515-2013)Siemens Medical Solutions USA, Inc2012-12-12
Siemens Mobilette Mira, intended use as Mobile x-ray system. recall (Z-0480-2013)Siemens Medical Solutions USA, Inc2012-12-06
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Process recall (Z-0465-2013)Siemens Medical Solutions USA, Inc2012-12-03
Siemens syngo.plaza radiological image processing system. recall (Z-0048-2013)Siemens Medical Solutions USA, Inc2012-10-11
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging recall (Z-2464-2012)Siemens Medical Solutions USA, Inc2012-09-26
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system recall (Z-2367-2012)Siemens Medical Solutions USA, Inc2012-09-11
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system recall (Z-2341-2012)Siemens Medical Solutions USA, Inc2012-09-10
Siemens Mobilett Mira. Mobile X-Ray System. recall (Z-2322-2012)Siemens Medical Solutions USA, Inc2012-09-06
syngo.plaza, Model number 10592457. Intended use: radiological image processing system. recall (Z-2275-2012)Siemens Medical Solutions USA, Inc2012-08-27
syngo Imaging XS. Radiological image processing system. recall (Z-2264-2012)Siemens Medical Solutions USA, Inc2012-08-24
syngo Dynamics Version 9.5 recall (Z-2219-2012)Siemens Medical Solutions, USA, Inc2012-08-17
Siemens syngo.plaza. Radiological image processing system recall (Z-2078-2012)Siemens Medical Solutions USA, Inc2012-07-26
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OI recall (Z-2073-2012)Siemens Medical Solutions USA, Inc2012-07-24
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compoun recall (Z-1684-2012)Siemens Medical Solutions USA, Inc.2012-05-30
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compoun recall (Z-1685-2012)Siemens Medical Solutions USA, Inc.2012-05-30
Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symb recall (Z-1686-2012)Siemens Medical Solutions USA, Inc.2012-05-30
e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomogr recall (Z-1687-2012)Siemens Medical Solutions USA, Inc.2012-05-30
Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear recall (Z-1675-2012)Siemens Medical Solutions USA, Inc2012-05-25
ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, U recall (Z-1616-2012)Siemens Medical Solutions USA, Inc.2012-05-16
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer recall (Z-1506-2012)Siemens Medical Solutions USA, Inc2012-05-10
Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging recall (Z-1494-2012)Siemens Medical Solutions USA, Inc2012-05-08
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). L recall (Z-1493-2012)Siemens Medical Solutions USA, Inc2012-05-07
Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ recall (Z-1486-2012)Siemens Medical Solutions USA, Inc2012-05-03
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/di recall (Z-1383-2012)Siemens Medical Solutions USA, Inc2012-04-09
Siemens MAGNETOM Verio Use: Nuclear resonance imaging system recall (Z-1364-2012)Siemens Medical Solutions USA, Inc2012-04-02
MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Ther recall (Z-1270-2012)Siemens Medical Solutions USA, Inc2012-03-21
Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. recall (Z-1184-2012)Siemens Medical Solutions USA, Inc2012-03-07
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray i recall (Z-1159-2012)Siemens Medical Solutions USA, Inc2012-03-05
Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image pro recall (Z-1127-2012)Siemens Medical Solutions USA, Inc2012-02-29
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Ma recall (Z-1092-2012)Siemens Medical Solutions USA, Inc2012-02-23
Siemens syngo Imaging XS. Radiological image processing system. recall (Z-1064-2012)Siemens Medical Solutions USA, Inc2012-02-20
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonan recall (Z-0940-2012)Siemens Medical Solutions USA, Inc2012-02-02
AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x recall (Z-0927-2012)Siemens Medical Solutions USA, Inc2012-01-27
Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-r recall (Z-0860-2012)Siemens Medical Solutions USA, Inc2012-01-25
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. recall (Z-0827-2012)Siemens Medical Solutions USA, Inc2012-01-20
Mevatron M2/PRIMUS Mid; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEV recall (Z-0780-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0781-2012)Siemens Medical Solutions USA, Inc2012-01-17
PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear recall (Z-0782-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0783-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and recall (Z-0784-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron 67; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0785-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6700 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0786-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6300 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0787-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6730/6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0788-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron MD (MD, MDX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVA recall (Z-0789-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0790-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron ME; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0791-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Line recall (Z-0792-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M2 6300; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON recall (Z-0793-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M2 6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON recall (Z-0794-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron MD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Lin recall (Z-0795-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Li recall (Z-0796-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Lin recall (Z-0797-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Li recall (Z-0798-2012)Siemens Medical Solutions USA, Inc2012-01-17
ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufac recall (Z-0459-2012)Siemens Medical Solutions USA, Inc2012-01-11
syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to c recall (Z-0462-2012)Siemens Medical Solutions USA, Inc2012-01-11
syngo Imaging XS, all versions Radiological image processing system recall (Z-0514-2012)Siemens Medical Solutions USA, Inc2012-01-11
syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image recall (Z-0515-2012)Siemens Medical Solutions USA, Inc2012-01-11
syngo.plaza Image processing system recall (Z-0522-2012)Siemens Medical Solutions USA, Inc2012-01-11
MAMMOMAT Inspiration Full field digital mammographic x-ray system recall (Z-0523-2012)Siemens Medical Solutions USA, Inc2012-01-11
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission recall (Z-0283-2012)Siemens Medical Solutions USA, Inc.2011-11-23
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Comp recall (Z-0284-2012)Siemens Medical Solutions USA, Inc.2011-11-23
ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemna recall (Z-3003-2011)Siemens Medical Solutions USA, Inc2011-08-11
Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system recall (Z-3009-2011)Siemens Medical Solutions USA, Inc2011-08-11
ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medi recall (Z-2977-2011)Siemens Medical Solutions USA, Inc2011-08-10
MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging recall (Z-2979-2011)Siemens Medical Solutions USA, Inc2011-08-10
Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the S recall (Z-2980-2011)Siemens Medical Solutions USA, Inc.2011-08-10
LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Ac recall (Z-2983-2011)Siemens Medical Solutions USA, Inc2011-08-10
Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic reson recall (Z-2786-2011)Siemens Medical Solutions USA, Inc2011-07-11
Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital image recall (Z-2787-2011)Siemens Medical Solutions USA, Inc2011-07-11
ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT recall (Z-2789-2011)Siemens Medical Solutions USA, Inc2011-07-11
syngo Dynamics Picture Archiving Communication System The software is a picture archiving recall (Z-2762-2011)Siemens Medical Solutions, USA, Inc2011-07-08
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