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Siemens Medical Solutions USA, Inc

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 1 recall (Z-0544-2009)Siemens Medical Solutions, USA, Inc2009-01-02
Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI; 1 recall (Z-0545-2009)Siemens Medical Solutions, USA, Inc2009-01-02
AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0312-2009)Siemens Medical Solutions USA, Inc2008-12-09
AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0313-2009)Siemens Medical Solutions USA, Inc2008-12-09
AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0314-2009)Siemens Medical Solutions USA, Inc2008-12-09
AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0315-2009)Siemens Medical Solutions USA, Inc2008-12-09
AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0316-2009)Siemens Medical Solutions USA, Inc2008-12-09
AXIOM Artis System dMP using software version VB31D with 30x40 cm2 flat detectors. AXIOM A recall (Z-0317-2009)Siemens Medical Solutions USA, Inc2008-12-09
syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The produc recall (Z-0324-2009)Siemens Medical Solutions USA, Inc2008-12-03
Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Mo recall (Z-0326-2009)Siemens Medical Solutions USA, Inc2008-11-28
Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager recall (Z-0327-2009)Siemens Medical Solutions USA, Inc2008-11-28
Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807. recall (Z-0120-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054. recall (Z-0121-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605. recall (Z-0122-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078. recall (Z-0123-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357. recall (Z-0124-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717. recall (Z-0125-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373. recall (Z-0126-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365. recall (Z-0127-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392. recall (Z-0128-2009)Siemens Medical Solutions USA, Inc2008-11-25
ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668. recall (Z-0133-2009)Siemens Medical Solutions USA, Inc2008-11-04
ANGIOSTAR Plus X-Ray System, Model number 6379718. recall (Z-0134-2009)Siemens Medical Solutions USA, Inc2008-11-04
MULTISTAR D X-Ray System, Model number 3772501. recall (Z-0135-2009)Siemens Medical Solutions USA, Inc2008-11-04
Coroskop X-Ray System, Model numbers 6258219 and 6379759. recall (Z-0136-2009)Siemens Medical Solutions USA, Inc2008-11-04
Bicor X-Ray System, Model number 9023136. recall (Z-0137-2009)Siemens Medical Solutions USA, Inc2008-11-04
Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383. recall (Z-0138-2009)Siemens Medical Solutions USA, Inc2008-11-04
MULTISTAR P X-Ray System, Model number 3773004. recall (Z-0139-2009)Siemens Medical Solutions USA, Inc2008-11-04
Coroskop Top X-Ray System, Model number 6134808. recall (Z-0140-2009)Siemens Medical Solutions USA, Inc2008-11-04
Coroskop C X-Ray System, Model numbers 6005636 and 9108572. recall (Z-0141-2009)Siemens Medical Solutions USA, Inc2008-11-04
MULTISTAR POLYDOROS X-Ray System, Model number 2845001 recall (Z-0142-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR HS X-Ray System, Model number 6005776 recall (Z-0143-2009)Siemens Medical Solutions USA, Inc2008-11-04
COROSKOP HS-ACS X-Ray System, Model number 6134659. recall (Z-0144-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR POLYDOROS X-Ray System, Model number 6134667. recall (Z-0145-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR TOP X-Ray System, Model number 6134816. recall (Z-0146-2009)Siemens Medical Solutions USA, Inc2008-11-04
NEUROSTAR X-Ray System, Model number 6134741. recall (Z-0147-2009)Siemens Medical Solutions USA, Inc2008-11-04
NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668. recall (Z-0148-2009)Siemens Medical Solutions USA, Inc2008-11-04
AXIOM Artis. Angiographic X-ray System. recall (Z-0193-2009)Siemens Medical Solutions USA, Inc2008-11-04
Axiom Artis Zee. Angiographic X-ray System. recall (Z-0194-2009)Siemens Medical Solutions USA, Inc2008-11-04
Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; recall (Z-0189-2009)Siemens Medical Solutions USA, Inc.2008-10-27
Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT sca recall (Z-0190-2009)Siemens Medical Solutions USA, Inc.2008-10-27
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE recall (Z-0116-2009)Siemens Medical Solutions USA, Inc2008-10-20
Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7 recall (Z-0163-2009)Siemens Medical Solutions USA, Inc2008-10-20
Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2 recall (Z-0089-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist System Part number 7339125 Medical charged-particle radiation therapy recall (Z-0090-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, an recall (Z-0091-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 recall (Z-0092-2009)Siemens Medical Solutions USA, Inc2008-10-16
AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW recall (Z-0093-2009)Siemens Medical Solutions USA, Inc2008-10-16
Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and P recall (Z-0094-2009)Siemens Medical Solutions USA, Inc2008-10-16
Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVI recall (Z-0095-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0096-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0097-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIME recall (Z-0098-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0099-2009)Siemens Medical Solutions USA, Inc2008-10-16
Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A recall (Z-0102-2009)Siemens Medical Solutions USA, Inc2008-10-15
AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve hi recall (Z-0101-2009)Siemens Medical Solutions USA, Inc2008-10-10
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to recall (Z-0111-2009)Siemens Medical Solutions USA, Inc.2008-10-10
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista recall (Z-0086-2009)Siemens Medical Solutions USA, Inc.2008-10-08
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communicati recall (Z-1751-2008)Siemens Medical Solutions, USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 8515520 e recall (Z-1753-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 recall (Z-1754-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 e recall (Z-1755-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 recall (Z-1756-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 eq recall (Z-1757-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number recall (Z-1758-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equ recall (Z-1759-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5 recall (Z-1760-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Ele recall (Z-1761-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital El recall (Z-1762-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Elect recall (Z-1763-2008)Siemens Medical Solutions USA, Inc2008-09-29
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a ge recall (Z-2468-2008)Siemens Medical Solutions USA, Inc.2008-09-29
SOMATOM Emotion 6. Computed tomography X-ray system recall (Z-2452-2008)Siemens Medical Solutions USA, Inc2008-09-21
SOMATOM Emotion 16. Computed tomography X-ray system recall (Z-2453-2008)Siemens Medical Solutions USA, Inc2008-09-21
Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software recall (Z-2212-2008)Siemens Medical Solutions USA, Inc.2008-09-19
Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system recall (Z-2095-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence recall (Z-2096-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 recall (Z-2097-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence Therapist RT recall (Z-2098-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence Ther recall (Z-2099-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence Therap recall (Z-2100-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2. recall (Z-2101-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist RTT2. recall (Z-2102-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapis recall (Z-2103-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2. recall (Z-2104-2008)Siemens Medical Solutions USA, Inc2008-09-17
Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Mod recall (Z-2230-2008)Siemens Medical Solutions USA, Inc.2008-09-11
Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 recall (Z-1768-2008)Siemens Medical Solutions USA, Inc2008-09-04
ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of t recall (Z-1766-2008)Siemens Medical Solutions USA, Inc.2008-09-02
Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of recall (Z-1767-2008)Siemens Medical Solutions USA, Inc.2008-09-02
Syn go Imaging XS is a picture archiving and communication system intended to display, pro recall (Z-1643-2008)Siemens Medical Solutions USA, Inc2008-08-24
Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equ recall (Z-1769-2008)Siemens Medical Solutions USA, Inc2008-08-20
Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and M recall (Z-2196-2008)Siemens Medical Solutions USA, Inc2008-06-28
syngo US Workplace Picture Archiving and Communication System, software version 2.0, Sieme recall (Z-1138-2008)Siemens Medical Solutions USA, Inc.2008-05-20
Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation thera recall (Z-0971-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation t recall (Z-0972-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle recall (Z-0973-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, recall (Z-0974-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part recall (Z-0975-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy syst recall (Z-0976-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Pa recall (Z-0977-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No recall (Z-0978-2008)Siemens Medical Solutions USA, Inc2008-04-30
Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 81394 recall (Z-0979-2008)Siemens Medical Solutions USA, Inc2008-04-30
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