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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

Cordis Corporation - S.M.A.R.T. Flex Biliary/Vascular selfexpanding stent system - Class 2 Recall
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 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

ESTEEM (Ambra Grisea, Lilium Tigrinum, Lycopodium Clavatum, Natrum Carbonicum, Viscum Album, Thuja Occidentalis, Hypothalamus (Suis), Cubeba Officinalis, Agnus Castus, Anacardium Orientale, Baryta Iodata, Lac Caninum, Lac Felinum, Naja Tripudians, Rhus Glabra, Rosa Damascena, Sabadilla, Aurum Metallicum, Magnesium Iodide, Carcinosinum) Liquid [Deseret Biologicals, Inc.]
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

GLUCOREG (Ascorbicum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Acetaldehyde, Dhea (Dehydroepiandrosterone), Phloridzinum, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipoicum Acidum, Citricum Acidum, Fumaricum Acidum, Glyoxal Trimer Dihydrate, Nadidum, Pantothenic Acid, Insulinum (Suis), Hepar Suis, Pancreas Suis, Glucagon, Baryta Oxalica, Alloxanum, Berberis Vulgaris, Carcinosin, Lycopodium Clavatum, Momordica Balsamina, Phosphoricum Acidum, Phosphorus,) Liquid [Deseret Biologicals, Inc.]
Updated Date: Nov 14, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 14, 2017 Category: Drugs & Pharmacology Source Type: alerts

Encore Medical, Lp - Cobalt HV Bone Cement - Class 2 Recall
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revis...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts

Encore Medical, Lp - Cobalt HV Bone Cement with Gentamicin - Class 2 Recall
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic ...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts

Encore Medical, Lp - Cobalt HV Bone Cement - Class 2 Recall
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revis...
Source: Medical Device Recalls - November 7, 2017 Category: Medical Devices Source Type: alerts

Encore Medical, Lp - Cobalt MV Bone Cement with Gentamicin - Class 2 Recall
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic ...
Source: Medical Device Recalls - November 7, 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

Elekta, Inc. - MOSAIQ Oncology Information System - Class 2 Recall
MOSAIQ Medical Charged-Particle Radiation Therapy System (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2017 Category: Medical Devices Source Type: alerts

HYPOTHALAMUS HP (Aralia Quinquefolia, Germanium Sesquioxide, Hydrocotyle Asiatica, Hypothalamus (Suis), Pineal (Suis), Hypophysis Suis, Polygonum Multiflorum, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Aug 7, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 7, 2017 Category: Drugs & Pharmacology Source Type: alerts

Xintec Corp - OptiLITE MultiUse Holmium Laser Fiber - Class 2 Recall
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 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

Atrium Medical Corporation - iCAST and Advanta - Class 2 Recall
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2017 Category: Medical Devices Source Type: alerts

Elekta, Inc. - MOSAIQ(R) Oncology Information System - Class 2 Recall
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ¿ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. Generate and keep medication formulary lists and calculate applicable ...
Source: Medical Device Recalls - June 28, 2017 Category: Medical Devices Source Type: alerts

Mobius Medical Systems, LP - Mobius 3D - Class 2 Recall
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 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

Philips Medical Systems (Cleveland) Inc - Brilliance BigBore Oncology CT - Class 2 Recall
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

LYMPH III (Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Atp (Adenosine Triphosphate Disodium), Co-Enzyme Q-10, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Mar 14, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 14, 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

CARCINOSINUM 200C (Carcinosinum) Pellet [Paramesh Banerji Life Sciences LLC]
Updated Date: Feb 3, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 3, 2017 Category: Drugs & Pharmacology 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

The Binding Site Group, Ltd. - Optilite Analyser - Class 2 Recall
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of ...
Source: Medical Device Recalls - January 14, 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