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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

LifeHealth, LLC - IRMA TRUPOINT - Class 2 Recall
LifeHealth, IRMA TRUPOINT model 443914 is typically used in point-of-care settings. The major components of the IRMA TRUPOINT system are a portable, battery-operated analyzer, and disposable cartridges that contain sensors and a calibrant. Cartridges come in a variety of analyte configurations. Cartridges calibrate with every test using the self-contained calibrant. Instructions displayed on the interactive touchscreen guide the user through all steps of the testing process. Patient and sample information can be entered during analysis. Test results are displayed within approximately 90 seconds after sample injection. Te...
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Triglycerides - Class 2 Recall
Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

New Star Lasers, Inc. - StoneLight 30 Laser System (NS3000) - Class 2 Recall
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) - Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re - Class 2 Recall
Bullet-Tip PEEKVBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 (01 )008464680341 08(17)191218(1 0)200827 MAX OOP,MQP; T-Pius PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6¿ lordotic 30-T-13-6 (01 )00846468032920(17)200116(10)202726 MAX ODP, MQP; & T-Pius PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6¿ lordotic 30-T-1036-13-6 (01 )00846468032760(17)200115(10)202582 MAX, ODP, MQP These products are part of the lnterbody FusionNertebral Body Replacement System. The lnterbody Fusion (IBF)Nertebral Body Replacement (VBR) System are implantable devices consisting of different footprints...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Pega Medical Inc. - SCFE Drivers of the FreeGliding SCFE Screw System - Class 2 Recall
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Navigation, Inc. - Medtronic Navigated Cannulated Taps - Class 2 Recall
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Synthes, Inc. - DePuy Synthes Titanium Recon Screws - Class 2 Recall
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Varian Medical Systems Inc - VariSource iX series - Class 2 Recall
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Perfusion Systems - DLP Femoral Arterial Cannula; DLP Femoral Cannula and Insertion Kit (w. Femoral Arterial Cannula) - Class 2 Recall
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it to aid ...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Vascutek, Ltd. - Gelseal - Class 2 Recall
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Vascutek, Ltd. - Gelseal - Class 2 Recall
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

HeartWare Inc - HeartWare Ventricular Assist System (HVAD) - Class 2 Recall
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

ITC-Nexus Dx - Surgicutt Bleeding Time Device - Class 2 Recall
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Xoran Technologies, Inc. - Minicat CT Scanner - Class 2 Recall
Xoran MiniCAT CT Scanner (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Merz Aesthetics, Inc. - MERZ AESTHETICS, 27G X 1.0 (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz - Class 3 Recall
MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Aesculap Implant Systems - Columbus Tibia Plateau (component of the Columbus REVISION Knee System) - Class 2 Recall
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - SIEMENS ADVIA Centaur CP Immunoassay System BNP kit. - Class 2 Recall
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of hart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system. (Source:...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - SIEMENS ADVIA Centaur CP Immunoassay System BNP kit. - Class 2 Recall
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of hart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system. (Source:...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

BD Biosciences, Systems & Reagents - BD Biosciences, Systems, and Reagents - Class 2 Recall
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Diamedix Corporation - IsantiSm test kit - Class 2 Recall
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Company - Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes - Class 2 Recall
BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS - Class 2 Recall
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered. The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric e...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Xoran Technologies, Inc. - MiniCAT CT Scanner - Class 2 Recall
Xoran MiniCAT00202 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Xoran Technologies, Inc. - Minicat CT Scanner - Class 2 Recall
Xoran Minicat00158 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Xoran Technologies, Inc. - Minicat CT Scanner - Class 2 Recall
Xoran Minicat00202 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts