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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 16.

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0mm with Panacryl without needles - Class 2 Recall
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0 w/out Needles with violet and blue Orthocord - Class 2 Recall
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0 w/Needles with Orthocord - Class 2 Recall
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

Nipro Medical Corporation - AquaLiner Hydrophilic Guidewire - Class 2 Recall
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0mm with Panacryl and needles - Class 2 Recall
SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5 w/Needles with violet and blue Orthocord - Class 2 Recall
SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5 w/out Needles with violet and blue Orthocord - Class 2 Recall
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5mm with Panacryl without needles - Class 2 Recall
Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5mm with Panacryl and needles - Class 2 Recall
SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5mm with Ethibond and needles - Class 2 Recall
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

Nipro Medical Corporation - AquaLiner Hydrophilic Guidewire - Class 2 Recall
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0 w/out Needles with Orthocord - Class 2 Recall
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5mm with Ethibond without needles - Class 2 Recall
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

Nipro Medical Corporation - AquaLiner Hydrophilic Guidewire - Class 2 Recall
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5 w/out Needles with Orthocord - Class 2 Recall
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0mm with Ethibond without needles - Class 2 Recall
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 6.5 w/Needles with Orthocord - Class 2 Recall
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - SpiraLok 5.0 w/Needles with violet and blue Orthocord - Class 2 Recall
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Source: Medical Device Recalls - October 25, 2012 Category: Medical Equipment Source Type: alerts

DePuy Mitek, Inc., a Johnson & Johnson Co. - VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece - Class 2 Recall
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Orthosensor - ORTHO SENSOR - Class 2 Recall
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Greatbatch Medical - MobiCath BiDirecctional Guiding Sheath. - Class 2 Recall
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the h...
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Perfusion System 8000 - Class 2 Recall
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel DxC 600/800 with - Class 2 Recall
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Seno Advantage 2.2 - Class 2 Recall
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Ormco/Sybronendo - Damon 3MX Bicuspid Bracket - Class 3 Recall
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Oncentra External Beam - Class 2 Recall
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Discovery NM/CT670; GE Discovery NM 630 - Class 2 Recall
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare 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 prod...
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Biomet 3i, LLC - Osseotite Tapered Certain Implant - Class 2 Recall
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Advandx Inc - E. coli/P. aeruginosa PNA FISH - Class 2 Recall
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Source: Medical Device Recalls - October 22, 2012 Category: Medical Equipment Source Type: alerts

Ethicon, Inc. - EVICEL - Class 2 Recall
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
Source: Medical Device Recalls - October 22, 2012 Category: Medical Equipment Source Type: alerts

Advanced Bionics Corporation - HiRes 90K - Class 2 Recall
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical e...
Source: Medical Device Recalls - October 22, 2012 Category: Medical Equipment Source Type: alerts

Advandx Inc - AdvanDx GNR Traffic Light PNA FISH - Class 2 Recall
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The...
Source: Medical Device Recalls - October 22, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Synchron Calibrator Multi Calibrator Diskettes - Class 3 Recall
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Source: Medical Device Recalls - October 22, 2012 Category: Medical Equipment Source Type: alerts

Westmed Inc - Pulset Arterial Blood Gas (ABG) sampling kit. - Class 2 Recall
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
Source: Medical Device Recalls - October 20, 2012 Category: Medical Equipment Source Type: alerts