Medical Equipment Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 38.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Source: Medical Device Recalls - May 11, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - CAPIOX RX Hollow Fiber Oxygenators - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15E Product Code: 74257
Source: Medical Device Recalls - May 11, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73673 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Source: Medical Device Recalls - May 11, 2012 Category: Medical Equipment Source Type: alerts

CaridianBCT, Inc. - Trima Accel - Class 2 Recall
Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.
Source: Medical Device Recalls - May 11, 2012 Category: Medical Equipment Source Type: alerts

Mitaka USA, Inc. - Point Setter - Class 2 Recall
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Source: Medical Device Recalls - May 11, 2012 Category: Medical Equipment Source Type: alerts

International Medsurg Connection, Inc. - 8 x 4 16ply XRay Gauze - Class 2 Recall
8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZX8416-10 For use to control bleeding and absorb fluid.
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

International Medsurg Connection, Inc. - 8 x 4 16ply Dual XRay Gauze - Class 2 Recall
8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10 For use to control bleeding and absorb fluid.
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Instrumentation Laboratory Co. - HemosIL von Willebrand Factor Activity Assay kit - Class 2 Recall
Instrumentation Laboratory (IL)HemosiL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Axiom Sensis XP - Class 2 Recall
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall
Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants whe...
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Stratus(R) CS Acute care(TM) NT - Class 2 Recall
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Abbott Laboratories - ARCHITECT STAT TroponinI Reagent Kit - Class 2 Recall
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angin...
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Cordis Corporation - Transhepatic Biliary Stent System - Class 2 Recall
Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545...
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - UltraDriveTool, 6 MM Plug Puller - Class 3 Recall
Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a...
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

Diamedix Corporation - HSV 1&2 IgM Enzyme Immunoassay Test Kit - Class 3 Recall
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intende...
Source: Medical Device Recalls - May 10, 2012 Category: Medical Equipment Source Type: alerts

O'Ryan Industries Inc - DISPOSASHIELD - Class 2 Recall
DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure...
Source: Medical Device Recalls - May 9, 2012 Category: Medical Equipment Source Type: alerts

MichClone Associates, Inc. - SickleScan - Class 2 Recall
Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
Source: Medical Device Recalls - May 9, 2012 Category: Medical Equipment Source Type: alerts

MichClone Associates, Inc. - Sickle Heme - Class 2 Recall
Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071. For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
Source: Medical Device Recalls - May 9, 2012 Category: Medical Equipment Source Type: alerts

MichClone Associates, Inc. - Biotron - Class 2 Recall
BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
Source: Medical Device Recalls - May 9, 2012 Category: Medical Equipment Source Type: alerts

CaridianBCT, Inc. - COBE Spectra - Class 2 Recall
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
Source: Medical Device Recalls - May 9, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Class 2 Recall
Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 Product Usage: Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - True Beam - Class 2 Recall
True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Zeus Scientific, Inc. - AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G - Class 3 Recall
AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55 - Class 2 Recall
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34 - Class 2 Recall
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47 - Class 2 Recall
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. For use in determining quantitative and / or qualitative antimicrobial agent susceptibility and / or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Doctor's Research Group, Inc. - Kryptonite Bone Cement - Class 2 Recall
Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects
Source: Medical Device Recalls - May 8, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Linear Accelerators in combination with 160MLC - Class 2 Recall
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plu...
Source: Medical Device Recalls - May 7, 2012 Category: Medical Equipment Source Type: alerts

Sandhill Scientific, Inc - Insight - Class 2 Recall
Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.
Source: Medical Device Recalls - May 7, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - LifeShield Primary Plumset - Class 2 Recall
LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.
Source: Medical Device Recalls - May 4, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Optima MR450W with GEM. - Class 2 Recall
GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
Source: Medical Device Recalls - May 4, 2012 Category: Medical Equipment Source Type: alerts

St Jude Medical CRMD - QuickSite, QuickSite XL - Class 2 Recall
Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
Source: Medical Device Recalls - May 3, 2012 Category: Medical Equipment Source Type: alerts

St Jude Medical CRMD - QuickFlex, QuickFlex XL - Class 2 Recall
Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead.
Source: Medical Device Recalls - May 3, 2012 Category: Medical Equipment Source Type: alerts

Pentax Medical Company - EG3870UTK, Pentax Ultrasound Video Gastroscope - Class 2 Recall
EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Source: Medical Device Recalls - May 3, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE, ONCOR and PRIMUS Linear Accelerator systems - Class 2 Recall
Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. Product Usage: The intended use of the SIEMENS branded ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Source: Medical Device Recalls - May 3, 2012 Category: Medical Equipment Source Type: alerts

Bomimed Inc - BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades - Class 2 Recall
BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
Source: Medical Device Recalls - May 3, 2012 Category: Medical Equipment Source Type: alerts

Wright Medical Technology Inc - VALOR(R), TARGETING GUIDE - Class 2 Recall
VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot s Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Source: Medical Device Recalls - May 2, 2012 Category: Medical Equipment Source Type: alerts

Wright Medical Technology Inc - VALOR(TM) TTC FUSION, INSTRUMENT KIT - Class 2 Recall
VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot s Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Source: Medical Device Recalls - May 2, 2012 Category: Medical Equipment Source Type: alerts

Coloplast Manufacturing US, LLC - Restorelle DirectFix Posterior Mesh - Class 3 Recall
Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Source: Medical Device Recalls - May 2, 2012 Category: Medical Equipment Source Type: alerts

Churchill Medical Systems, Inc. - Churchill Medical Systems 22Ga Winged Infusion Set - Class 2 Recall
Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports.
Source: Medical Device Recalls - May 1, 2012 Category: Medical Equipment Source Type: alerts