Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc - PATHFAST MyoII - Class 2 Recall
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2018 Category: Medical Devices Source Type: alerts

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc - PATHFAST NTproBNP - Class 2 Recall
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts

Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts

Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts

Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Impression - Class 2 Recall
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Impression Plus - Class 2 Recall
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Avantgarde - Class 2 Recall
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - PRIMUS HI - Class 2 Recall
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON M2 / PRIMUS MidEnergy, - Class 2 Recall
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Expression - Class 2 Recall
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

DePuy Spine, Inc. - Confidence Plus Kit Spinal Cement System - Class 2 Recall
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2018 Category: Medical Devices Source Type: alerts

Life Technologies Corporation - Oncomine Dx Target Test - Class 2 Recall
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therap...
Source: Medical Device Recalls - March 31, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Healthcare SOMATOM Go.Up - Class 2 Recall
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literat...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Healthcare SOMATOM Go.Now - Class 2 Recall
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent litera...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using eit...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - ASPIRE Cristalle - Class 2 Recall
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - Aspire HD - Class 2 Recall
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts

AMMONIA N 13 (Ammonia N-13) Injection [The University Of Texas MD Anderson Cancer Center]
Updated Date: Dec 21, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 21, 2017 Category: Drugs & Pharmacology Source Type: alerts

MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT (Sodium Monofluorophosphate) Kit [ASP Global, LLc]
Updated Date: Dec 15, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2017 Category: Drugs & Pharmacology Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia Intevo 16 - Class 2 Recall
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia Intevo 6 - Class 2 Recall
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either ...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts

Nucletron BV - Oncentra Brachy 4.5 - Class 2 Recall
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - MSH6 (44 Mab) CM - Class 2 Recall
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MRI - Class 2 Recall
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is i...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for t...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for th...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT (Sodium Monofluorophosphate) Kit [Anatomy Supply Partners, LLc]
Updated Date: Apr 3, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 3, 2017 Category: Drugs & Pharmacology Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON M 6700 (MX) - Class 2 Recall
MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON M 6730/6740 (MEX) - Class 2 Recall
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - PRIMUS HI - Class 2 Recall
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON M 6730/6740 (MEX) - Class 2 Recall
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON KD2 - Class 2 Recall
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - MEVATRON M 6730/6740 (MEX) - Class 2 Recall
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Primus and Primus Plus - Class 2 Recall
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Avant - Class 2 Recall
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE MV System - Class 2 Recall
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ONCOR Impression - Class 2 Recall
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000 Third Generation PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000, Third Generation PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(64)4R - Class 2 Recall
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - BIOGRAPH mCT 20 Excel - Class 2 Recall
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Bio mCTS(40) 3R4R Upgrade - Class 2 Recall
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of d...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT Flow 404R - Class 2 Recall
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determini...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X3R - Class 2 Recall
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts