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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

Siemens Medical Solutions USA Inc. - Biograph mCT Flow Edge4R - Class 2 Recall
Biograph mCT Flow Edge-4R, Material Number 10528955 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 determi...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X4R - Class 2 Recall
Biograph mCT X-4R, Material Number 10248670 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

Siemens Medical Solutions USA Inc. - Biograph mCT S(40)4R - Class 2 Recall
Biograph mCT S(40)-4R, Material Number 10248671 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 S(64)3R - Class 2 Recall
Biograph mCT S(64)-3R, Material Number 10248669 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 S(40)3R - Class 2 Recall
Biograph mCT S(40)-3R, Material Number 10248668 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 mCTX w/TrueV Upgrade - Class 2 Recall
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 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 de...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Oncentra External Beam Treatment Planning Software - Class 2 Recall
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 2000 PSA Assay - Class 2 Recall
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi 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 exam...
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000 PSA - Class 2 Recall
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi 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 o...
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - SynchroMed II Implantable Drug Infusion System - Class 2 Recall
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free...
Source: Medical Device Recalls - December 20, 2016 Category: Medical Equipment Source Type: alerts

FLUDEOXYGLUCOSE F18 Injection [Memorial Sloan Kettering Cancer Center]
Updated Date: Dec 19, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 19, 2016 Category: Drugs & Pharmacology Source Type: alerts

CHOLINE C 11 Injection [The University Of Texas MD Anderson Cancer Center]
Updated Date: Dec 6, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 6, 2016 Category: Drugs & Pharmacology Source Type: alerts

Siemens Medical Solutions USA, Inc - PRIMUS Accelerator, Linear, Medical - Class 2 Recall
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2016 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE Accelerator, Linear, Medical - Class 2 Recall
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2016 Category: Medical Equipment Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY) - Class 2 Recall
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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 - August 31, 2016 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Roche Molecular Diagnostics Inc. - Class 2 Recall
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2016 Category: Medical Equipment Source Type: alerts

ORTHO-CLINICAL DIAGNOSTICS - VITROS Immunodiagnostic Products AFP Reagent Pack - Class 3 Recall
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Sy...
Source: Medical Device Recalls - July 9, 2016 Category: Medical Equipment Source Type: alerts

Dako North America Inc. - Dako HER2 CISH pharmDx Kit - Class 2 Recall
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Leica Biosystems Richmond Inc. - Class 3 Recall
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, ...
Source: Medical Device Recalls - June 11, 2016 Category: Medical Equipment Source Type: alerts

Skyla (levonorgestrel-releasing intrauterine system)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) April 2016 WARNINGS AND PRECAUTIONS Breast Cancer Observational studies of the risk of breast cancer with use of a LNG-releasing... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts