GE Medical Systems, LLC - GE Healthcare MRI Systems, Software Version 15.x or HD 16 - Class 2 Recall
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T E...
Source: Medical Device Recalls - October 16, 2018 Category: Medical Devices Source Type: alerts

Becton Dickinson & Co. - BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station - Class 3 Recall
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2018 Category: Medical Devices Source Type: alerts

Biocare Medical, LLC - URO3 Triple Stain (CD44 p52 CK20) - Class 2 Recall
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining or...
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts

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

Intuitive Surgical, Inc. - Intuitive Surgical da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts

Intuitive Surgical, Inc. - Intuitive Surgical da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts

Elekta, Inc. - MOSAIQ Oncology Information System - Class 2 Recall
MOSAIQ Oncology Information System (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2018 Category: Medical Devices Source Type: alerts

HYPOTHALAMUS HP (Aralia Quinquefolia, Germanium Sesquioxide, Hydrocotyle Asiatica, Hypophysis Suis, Hypothalamus Suis, Pineal Gland (Suis), Polygonum Multiflorum, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Aug 3, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 3, 2018 Category: Drugs & Pharmacology Source Type: alerts

Forte Automation Systems Inc - PATIENT POSITIONING SYSTEM - Class 2 Recall
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2018 Category: Medical Devices 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, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Jun 14, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 14, 2018 Category: Drugs & Pharmacology 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

Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance Big Bore (Oncology) - Class 2 Recall
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 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

LYMPH III (Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Mar 8, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 8, 2018 Category: Drugs & Pharmacology Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Oncology CT - Class 2 Recall
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 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

Integra LifeSciences Corp. - Footswitch accessory - Class 2 Recall
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery in...
Source: Medical Device Recalls - February 24, 2018 Category: Medical Devices Source Type: alerts

SPECTRIC (Ethylicum, Kali Bromatum, Aspartic Acid, L-Dopa, Serotonin (Hydrochloride), Cerebrum Suis, Placenta Totalis Suis, Agaricus Muscarius, Bufo Rana, Helleborus Niger, Hyoscyamus Niger, Olibanum (Boswellia Serrata), Stramonium, Thuja Occidentalis, Helium, Neon, Carcinosin, Hydrogen) Liquid [Deseret Biologicals, Inc]
Updated Date: Feb 22, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 22, 2018 Category: Drugs & Pharmacology 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

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