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

ArthroCare Medical Corporation - Coblator II System - Class 2 Recall
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) ...
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts

Ameda, Inc. - Class 2 Recall
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts

Ameda, Inc. - Class 2 Recall
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts

TITAN SPINE, LLC - Endo TCS Driver Straight Hexalobe 6 P/N 52101004, - Class 2 Recall
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC, 6140 W Executive Dr., Suite A, Mequon, WI 53092, USA. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - ADVIA Chemistry Systems Drug Calibrator I - Class 2 Recall
ADVIA¿ Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. ...
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

In2Bones, SAS - DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003 - Class 2 Recall
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

In2Bones, SAS - DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002 - Class 2 Recall
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Company - BD QSyte Luer Access Split Septum - Class 2 Recall
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Roche Molecular Diagnostics Inc. - Class 3 Recall
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

Ossur H / F - Rheo Knee - Class 2 Recall
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the user s walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the user s ability to walk naturally, comfortably and confidently at any speed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

Brainlab AG - Class 2 Recall
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2015 Category: Medical Equipment Source Type: alerts

Leica Microsystems, Inc. - Class 2 Recall
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient s clinical history and other diagnostic tests by a qualified pathologist. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - GE Healthcare Engstrom Carestation and Engstrom Pro - Class 2 Recall
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2015 Category: Medical Equipment Source Type: alerts

Flower Orthopedics Corporation - Flower Orthopedics Small and Medium Implants Set - Class 2 Recall
Flower Orthopedics Small and Medium Implants Set; Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm , Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm ; Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm; the locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2015 Category: Medical Equipment Source Type: alerts

Flower Orthopedics Corporation - Flower Orthopedics Variable Angle Locking Peg - Class 2 Recall
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2015 Category: Medical Equipment Source Type: alerts

CareFusion 303, Inc. - Alaris - Class 2 Recall
Alaris PC units, Model No. 8015 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2015 Category: Medical Equipment Source Type: alerts

Synthes, Inc. - Synthes Electric Pen Drive (EPD) System - Class 2 Recall
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2015 Category: Medical Equipment Source Type: alerts

Advanced Sterilization Products - Tyvek Roll with STERRAD Chemical Indicator - Class 2 Recall
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2015 Category: Medical Equipment Source Type: alerts

Aaren Scientific, Incorporated - Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL - Class 2 Recall
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientific s EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens MAGNETOM systems - Class 2 Recall
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physici...
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - da Vinci Xi Surgical System - Class 2 Recall
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and deliv...
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - da Vinci Xi Surgical System - Class 2 Recall
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placeme...
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - da Vinci Xi Surgical System - Class 2 Recall
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and del...
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - Multiple GE MRI systems - Class 2 Recall
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts

Cardiovascular Systems, Inc. - Diamondback 360 Coronary Orbital Artherctomy System - Class 1 Recall
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts