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 thera...
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 litera...
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 liter...
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 i...
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
