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

Olympus America Inc. - Olympus SurgMaster UES40 electrosurgical unit (UES40) - Class 2 Recall
Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - SERVOi ventilator system - Class 1 Recall
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-...
Source: Medical Device Recalls - April 26, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Class 2 Recall
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patient s respiratory motion information to synchronize their operation with the respiratory motion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2013 Category: Medical Equipment Source Type: alerts

Engineered Medical Systems,Inc - SealFlex - Class 1 Recall
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - ELS Cannula 15 FR - Class 2 Recall
ELS Cannula 15 FR. Used for the treatment of respiratory insufficiency in infants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2013 Category: Medical Equipment Source Type: alerts

Diagnostic Hybrids Inc - Diagnostic Hybrids Inc. - Class 3 Recall
Diagnostic Hybrids, Inc., 1055 East State Street, Suite 100, Athens, OH 45701. Primary monkey kidney tissue cultures are intended to be used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens. Primary monkey kidney tissue cultures are used to amplify viruses to a detectable level from patient specimens that are sent by physicians for the purpose of identifying a stated virus or virus group. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Class 2 Recall
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements...
Source: Medical Device Recalls - December 17, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Dash 3000/4000/5000. - Class 2 Recall
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medi...
Source: Medical Device Recalls - December 16, 2012 Category: Medical Equipment Source Type: alerts

Bunnell, Inc. - Life Pulse High Frequency Ventilator - Class 1 Recall
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their phys...
Source: Medical Device Recalls - December 14, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - AirFlow, Small Adult Resuscitator - Class 1 Recall
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Ventlab Premium Small Adult Resuscitator - Class 1 Recall
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - StatCheck Resuscitator - Class 1 Recall
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - VCare Resuscitator Infant Resuscitator - Class 1 Recall
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - AirFlow, Infant Resuscitator - Class 1 Recall
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Ventlab Rescue Med Infant Resuscitator - Class 1 Recall
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - AirFlow Resuscitator, Adult Resuscitator - Class 1 Recall
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Breath Tech, Safe Spot Infant Resuscitator - Class 1 Recall
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Adult Resuscitator, Pro5000 Series - Class 1 Recall
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Safe Spot Infant Resuscitator - Class 1 Recall
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Ventlab Corporation - Safe Spot Infant Resuscitator - Class 1 Recall
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Respironics California Inc - V60 Ventilator - Class 1 Recall
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the n...
Source: Medical Device Recalls - August 31, 2012 Category: Medical Equipment Source Type: alerts

Princeton Biomeditech Corp - Orasure QuickFlu Rapid AB Test - Class 2 Recall
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclud...
Source: Medical Device Recalls - August 31, 2012 Category: Medical Equipment Source Type: alerts

Princeton Biomeditech Corp - Poly stat Flu A & B Test - Class 2 Recall
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be co...
Source: Medical Device Recalls - August 31, 2012 Category: Medical Equipment Source Type: alerts

Princeton Biomeditech Corp - Status Flu A B Test - Class 2 Recall
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not p...
Source: Medical Device Recalls - August 31, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - V Series Monitor - Class 2 Recall
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of perfo...
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Impact Instrumentation, Inc. - Model EMV UniVent - Class 3 Recall
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 7, 2012 Category: Medical Equipment Source Type: alerts

CareFusion 203, Inc. - EnVe Ventilator - Class 1 Recall
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2012 Category: Medical Equipment Source Type: alerts

Carefusion 2200 Inc - AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, NonHeated - Class 1 Recall
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

Carefusion 2200 Inc - AirLife Isothermal Breathing Circuit Accessory Infant Patient Y Connector - Class 1 Recall
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

Carefusion 2200 Inc - AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated - Class 1 Recall
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Multi Diagnost Eleva II with swivel cable - Class 2 Recall
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography (Sou...
Source: Medical Device Recalls - June 20, 2012 Category: Medical Equipment Source Type: alerts

Maquet Inc. - Servoi ventilator system - Class 2 Recall
Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 3, 2012 Category: Medical Equipment Source Type: alerts

Maquet Inc. - Servoi ventilator system - Class 2 Recall
Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 3, 2012 Category: Medical Equipment Source Type: alerts

Olympus America Inc. - Olympus Mobile Workstations - Class 2 Recall
Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - V Series Monitor - Class 2 Recall
V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips MultiDiagnost Eleva IITV - Class 2 Recall
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips MultiDiagnost Eleva FD (MDFD) - Class 2 Recall
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2012 Category: Medical Equipment Source Type: alerts

SALTER LABS - Salter Labs Bubble humidifier - Class 1 Recall
Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2012 Category: Medical Equipment Source Type: alerts

Carefusion 211 Inc - AVEA Ventilator - Class 1 Recall
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Multi Diagnost Eleva - Class 2 Recall
Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and various : Arthrograms, Myelograms , Facet joint injections , Discography, Sialography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

A M Systems Inc - A M Systems ViroMax viral/bacterial filter - Class 2 Recall
ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Case Report: Gastric Band Migrates
(MedPage Today) -- Serious respiratory problems, including lung damage, can result from malfunction of adjustable gastric bands implanted in obese patients, said British doctors in a case report. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - December 21, 2011 Category: Drugs & Pharmacology Source Type: alerts

Maquet Inc. - Servoi ventilator system - Class 2 Recall
Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

Maquet Inc. - PC Board PC1772 Spare PArt - Class 2 Recall
Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

Maquet Inc. - ServoS ventilator system - Class 2 Recall
Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

CareFusion 203, Inc. - EnVe Ventilator - Class 1 Recall
CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2011 Category: Medical Equipment Source Type: alerts

Salter Laboratories, Division of Regulatory Affairs - Nebulizer - Class 2 Recall
Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2011 Category: Medical Equipment Source Type: alerts

Salter Laboratories, Division of Regulatory Affairs - Mask adult, oxygen, medium concentration, elastic strap - Class 2 Recall
Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2011 Category: Medical Equipment Source Type: alerts

Salter Laboratories, Division of Regulatory Affairs - Mask adult, elastic strap style, PercentO2 Lock air entrainment system - Class 2 Recall
Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2011 Category: Medical Equipment Source Type: alerts

Salter Laboratories, Division of Regulatory Affairs - Mask adult, oxygen, medium concentration, nonbreathing - Class 2 Recall
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2011 Category: Medical Equipment Source Type: alerts