Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2034-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2032-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2031-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2029-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64 – 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2013-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information… Recall Number Z-2036-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2035-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information., Recall Number Z-2005-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2033-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2030-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT S(20) – 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2028-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2022-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2012-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2010-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 – 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2007-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2008-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2037-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2006-2016 REASON Siemens Medical...Read More

Company: Leica Biosystems Richmond Inc. Date of Enforcement Report 6/29/2016 Class lI: PRODUCT CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist...Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System)...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2018-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2017-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2027-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2026-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2024-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2021-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2015-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2014-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2023-2016 REASON Siemens Medical...Read More