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 21.

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 18 LX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 25 SX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 16 Slice (Air) - Class 3 Recall
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH - Class 3 Recall
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur systems Calibrator B for Prolactin - Class 3 Recall
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿ Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Precise Digital Accelerator - Class 2 Recall
Precise Digital Accelerator Delivery of radiation to defined target volumes
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Amplilink Software v3.2 - Class 2 Recall
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Source: Medical Device Recalls - September 18, 2012 Category: Medical Equipment Source Type: alerts

Bio-Rad Laboratories - MONOLISA ANTIHBs EIA - Class 2 Recall
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or...
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Vascular Solutions, Inc. - Guardian II NC Hemostasis Valve with Guidewire Introducer - Class 2 Recall
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Biomet Juggerknot in Guide Punch - Class 2 Recall
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

BD Biosciences, Systems & Reagents - BD FACS 7color Setup Beads - Class 2 Recall
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

US Endoscopy Group Inc - Infinity sampling device, Cytology Brush - Class 2 Recall
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

ZOLL Medical Corporation - Class 2 Recall
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the moni...
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - Amsco 3085SP Surgical Table - Class 2 Recall
A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Empty Evacuated Container 250 mL and 1000 mL. - Class 2 Recall
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Amsino Medical USA - 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 10 mL in 12 mL Single Use Syringe - Class 3 Recall
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Source: Medical Device Recalls - September 15, 2012 Category: Medical Equipment Source Type: alerts

Amsino Medical USA - 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe - Class 3 Recall
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Source: Medical Device Recalls - September 15, 2012 Category: Medical Equipment Source Type: alerts

Zoe Medical Incorporated - Ultraview DM3 Monitor - Class 2 Recall
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Tedan Surgical Innovations Llc - Sterile Distraction Screws of 3 different sizes - Class 2 Recall
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Varian brand Clinac, Trilogy, Novalis Tx Unique, linear accelerators - Class 2 Recall
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - MX 16slice - Class 2 Recall
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Integra Life Sci. - Integra 2.7 mm Drilling Guide - Class 2 Recall
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate...
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

RAYSEARCH LABORATORIES AB - RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan - Class 2 Recall
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 . Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, fo...
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Covidien LLC - HALO Flex Energy Generators - Class 2 Recall
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Instrumentation Laboratory Co. - Automated Coagulation Analyzer - Class 2 Recall
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips DigitalDiagnost Systems - Class 2 Recall
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Instrumentation Laboratory Co. - Automated Coagulation Analyzer - Class 2 Recall
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Spacelabs Healthcare, Llc - Integrated Module Housing - Class 2 Recall
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as...
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Instrumentation Laboratory Co. - Automated Coagulation Analyzer - Class 2 Recall
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Capsule Tech Inc. - Capsule Neuron Docking Station - Class 2 Recall
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Omni Life Science - Omnilife Science Apex Knee System Modular Tibia Augment - Class 2 Recall
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Optima - Class 2 Recall
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Omni Life Science - Omnilife Science Apex Knee System Modular Tibia Augment - Class 2 Recall
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular Xray imaging systems. - Class 2 Recall
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography app...
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Omni Life Science - Omnilife Science Apex Knee System Modular Tibia Augment - Class 2 Recall
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Optima - Class 2 Recall
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Omni Life Science - Omnilife Science Apex Knee System Modular Tibia Augment - Class 2 Recall
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Biosense Webster, Inc. - CARTO 3 V1.05 System - Class 2 Recall
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintainin...
Source: Medical Device Recalls - September 12, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns System 8000 - Class 2 Recall
Safety monitor included with System 8000 Base 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. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
Source: Medical Device Recalls - September 11, 2012 Category: Medical Equipment Source Type: alerts

Lucero Medical LLC - Enduramesh Corpectomy Spacer System - Class 2 Recall
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Source: Medical Device Recalls - September 11, 2012 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - NOVATION MODULAR DRILL BIT - Class 2 Recall
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Source: Medical Device Recalls - September 11, 2012 Category: Medical Equipment Source Type: alerts