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Nephron Pharmaceuticals Corp. - Sodium Chloride Inhalation Solution - Class 2 Recall
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2016 Category: Medical Equipment Source Type: alerts

Nephron Pharmaceuticals Corp. - Sodium Chloride Inhalation Solution - Class 2 Recall
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2016 Category: Medical Equipment Source Type: alerts

Ventlab LLC - STATCheck - Class 2 Recall
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients> 2.2 kilograms (5lbs.). (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2016 Category: Medical Equipment Source Type: alerts

Imbruvica (ibrutinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) June 2016 ADVERSE REACTIONS Postmarketing Experience (Addition) Respiratory disorders: interstitial lung disease (includes... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
Manufacturing defect causes an increase in temperature within battery that may cause a fire. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 27, 2016 Category: American Health Source Type: alerts

Philips Medical Systems, Inc. - Philips MultiDiagnost - Class 2 Recall
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be 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, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2016 Category: Medical Equipment Source Type: alerts

Klonopin (clonazepam) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   March 2016 PRECAUTIONS Respiratory Compromise: Klonopin should be used with caution in patients with compromised respiratory... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals: Recall - Super-potent Product
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 17, 2016 Category: American Health Source Type: alerts

Mercury Enterprises, Inc. dba Mercury Medical - Mercury Medical NeoTee - Class 2 Recall
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2016 Category: Medical Equipment Source Type: alerts

Botox (onabotulinumtoxinA) 
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) January 2016 WARNINGS AND PRECAUTIONS Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Event Medical LTD - Inspiration Ventilator System - Class 1 Recall
Inspiration Ventilator System, i Series and LS 12.1 LCD The Inspiration 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support w...
Source: Medical Device Recalls - November 20, 2015 Category: Medical Equipment Source Type: alerts

Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Puritan Bennett 980 Ventilator System Universal and Neonatal Models - Class 1 Recall
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts

Alere Scarborough, Inc. dba Binax, Inc. - Alere i flu, Alere i, Alere Influenza A & B - Class 2 Recall
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended ...
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts

Breas Medical AB - Breas Vivo 50 Home Care Ventilator - Class 2 Recall
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - Dfend and Dfend water trap - Class 2 Recall
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient s respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (a...
Source: Medical Device Recalls - May 29, 2015 Category: Medical Equipment Source Type: alerts

Alere Scarborough, Inc. dba Binax, Inc. - Alere i Influenza A & B - Class 2 Recall
Alere i Influenza A & B Product Usage: The Alere i Influenza A & B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C ...
Source: Medical Device Recalls - May 27, 2015 Category: Medical Equipment Source Type: alerts

Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Puritan Bennett 980 Ventilator System - Class 2 Recall
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube...
Source: Medical Device Recalls - February 6, 2015 Category: Medical Equipment Source Type: alerts

Aptalis Pharmatech Inc. - FLUTTER - Class 2 Recall
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 23, 2015 Category: Medical Equipment Source Type: alerts

Invacare Corporation - Invacare Perfecto 2 V Oxygen Concentrator - Class 2 Recall
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. dba Mindray North America - Mindray V21 - Class 2 Recall
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying speci...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Carefusion 2200 Inc - Class 2 Recall
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

CareFusion 203, Inc. - The EnVe/ ReVel Ventilator - Class 1 Recall
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2014 Category: Medical Equipment Source Type: alerts

EMG Technology Co., Ltd. - VacAssist Suction Units - Class 2 Recall
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - CARESCAPE Respiratory Modules, EsCO, EsCOV, EsCAiO and EsCAiOV and accessories - Class 2 Recall
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 10, 2014 Category: Medical Equipment Source Type: alerts

Ansar Group, Inc. Dba Ansar Medical Technologies, Inc - ANSAR ANX3.0 Autonomic Monitor system - Class 2 Recall
blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of FDA 510 K market clearance components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, 510 K number K001775; Zoe Medical Nightingale Monitoring system, 510 K number; Ivy Biom...
Source: Medical Device Recalls - August 20, 2014 Category: Medical Equipment Source Type: alerts

Teleflex Medical - Hudson RCI - Class 2 Recall
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use, Teleflex Medical, Research Triangle Park, NC 27709. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts

Teleflex Medical - Hudson RCI - Class 2 Recall
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Humidifier, Respiratory Gas, (Direct Patient Interface)], Teleflex Medical, Research Triangle Park, NC 27709. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. dba Mindray North America - VSeries - Class 2 Recall
V-Series Patient Monitoring System, Manufactured in China for Mindray DS USA, Inc. Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Indications for use include 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 (BP); Invasive BP; Cardiac Output (CO); Respiratory Gasses; Respiratory Rate; and Temperature. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations ...
Source: Medical Device Recalls - July 17, 2014 Category: Medical Equipment Source Type: alerts

Teleflex Medical - Aquapak 340 SW, 340, mL w/040 Adaptor - Class 2 Recall
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2014 Category: Medical Equipment Source Type: alerts

Ventlab LLC - Ventlab Manual Resuscitators - Class 1 Recall
Ventilator, emergency, manual resuscitator for the Pediatric Population Product Usage: Device is used in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2014 Category: Medical Equipment Source Type: alerts

Focus Diagnostics Inc - Simplexa Flu A/B &38; RSV Direct - Class 2 Recall
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of i...
Source: Medical Device Recalls - July 2, 2014 Category: Medical Equipment Source Type: alerts

Nellcor Puritan Bennett Inc. (dba Covidien LP) - Puritan Bennett 840 Ventilator - Class 2 Recall
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - DatexOhmeda S/5MT Compact Airway Module - Class 2 Recall
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. Product Usage: The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient s respiration (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption V02, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N20+02 mixtures. The device is indicated for use by qualified medic...
Source: Medical Device Recalls - June 18, 2014 Category: Medical Equipment Source Type: alerts

Nellcor Puritan Bennett Inc. (dba Covidien LP) - PB840 Ventilator Printed Circuit Board - Class 2 Recall
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2014 Category: Medical Equipment Source Type: alerts

Bacterin International, Inc. - Elutia Surgical Wound Drain - Class 2 Recall
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2014 Category: Medical Equipment Source Type: alerts

Nellcor Puritan Bennett Inc. (dba Covidien LP) - Newport Medical Instruments e360 Ventilator - Class 2 Recall
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 10, 2014 Category: Medical Equipment Source Type: alerts

Draeger Medical Systems, Inc. - Draeger Oxylog 3000 plus ventilators - Class 1 Recall
Draeger Oxylog 3000 plus ventilators Product Usage: The Oxylog 3000 plus is a time-cycled, volume controlled and pressure-controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards. Intended operator: the device is intended for use by and under the supervision of trained healthcare professionals, e.g. doctors, nurses, emergency medical technicians, respiratory therapists, and paramedics. Intended environment of use: Mobile use for emergency patients, in both outdoor and indoor environments. During transport in ambulances or aircraft, inclu...
Source: Medical Device Recalls - April 11, 2014 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - iSTAT G3 Cartridge - Class 2 Recall
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Optima CT580/Discovery CT590RT scanners - Class 2 Recall
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood ...
Source: Medical Device Recalls - March 12, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 - Class 2 Recall
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, gener...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - CARESCAPE Monitor B850 - Class 2 Recall
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et...
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts

ArjoHuntleigh Inc. - Rotoprone Therapy System - Class 2 Recall
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics. ...
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardi...
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Maquet Compressor Mini - Class 2 Recall
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts

Focus Diagnostics Inc - Simplexa Flu A/B & RSV Direct assay - Class 2 Recall
Simplexa" Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans an...
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Solar 8000 and Transport Pro with Patient Data Module (Marketed as CARESCAPE Patient Data Module) - Class 2 Recall
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, ...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 - Class 2 Recall
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric no...
Source: Medical Device Recalls - December 13, 2013 Category: Medical Equipment Source Type: alerts