Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2019 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: May 6, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 6, 2019 Category: Drugs & Pharmacology Source Type: alerts
GE Healthcare, LLC - NM/CT 870 DR - Class 2 Recall
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to pr...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 ES - Class 2 Recall
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is inte...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 CZT - Class 2 Recall
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is inte...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
ICU Medical, Inc. - icumedical Oncology Kit - Class 1 Recall
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 16, 2019 Category: Medical Devices Source Type: alerts
ICU Medical, Inc. - icumedical Oncology Kit - Class 1 Recall
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 16, 2019 Category: Medical Devices Source Type: alerts
Elekta Limited - Elekta Unity - Class 2 Recall
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts
Another Day, Another ARB, Another Contaminant
(MedPage Today) -- Losartan lots from Indian drugmaker recalled for novel carcinogen (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - March 26, 2019 Category: Drugs & Pharmacology Source Type: alerts
Elekta, Inc. - MOSAIQ Oncology Information System and Sequencer - Class 2 Recall
MOSAIQ¿ Oncology Information System and Sequencer 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2019 Category: Medical Devices Source Type: alerts
Varian Medical Systems, Inc. - Eclipse(TM) Treatment Planning System - Class 2 Recall
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2019 Category: Medical Devices Source Type: alerts
Waldemar Link GmbH & Co. KG (Mfg Site) - LINK STEM with Microporous Surface MP Reconstruction Prosthesis - Class 2 Recall
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femora...
Source: Medical Device Recalls - January 15, 2019 Category: Medical Devices Source Type: alerts
Elekta, Inc. - MOSAIQ Oncology Information System - Class 2 Recall
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 28, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 DR - Class 2 Recall
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2018 Category: Medical Devices Source Type: alerts
VITRAKVI (Larotrectinib) Capsule VITRAKVI (Larotrectinib) Solution [Loxo Oncology, Inc.]
Updated Date: Dec 6, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 6, 2018 Category: Drugs & Pharmacology Source Type: alerts
