EMERGENCY ZIT STICK ACNE TREATMENT (Salicylic Acid) Stick [Basic Research]
Updated Date: May 1, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - May 1, 2014 Category: Drugs & Pharmacology Source Type: alerts
GE OEC Medical Systems, Inc - OEC 9900 Elite - Class 2 Recall
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2014 Category: Medical Equipment Source Type: alerts
Newport Medical Instruments Inc - Ventilator - Class 1 Recall
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hosp...
Source: Medical Device Recalls - April 15, 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, in...
Source: Medical Device Recalls - April 11, 2014 Category: Medical Equipment Source Type: alerts
ZOLL Medical Corporation - Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor - Class 2 Recall
Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the trans...
Source: Medical Device Recalls - April 1, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems North America Inc. - Philip's HeartStart FR3 Automated External Defibrillator (AED) - Class 2 Recall
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA wit...
Source: Medical Device Recalls - March 20, 2014 Category: Medical Equipment Source Type: alerts
CEDERROTH EMERGENCY EYE WASH (Water) Liquid [Cederroth Ab]
Updated Date: Mar 13, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - March 13, 2014 Category: Drugs & Pharmacology Source Type: alerts
Shimadzu Medical Systems - MUX100, MUX100H Xray System - Class 2 Recall
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 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, general...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Emergency Powered Ventilator Resusicitator - Class 1 Recall
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate s transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Giraffe and Panda Warmer TPiece Resuscitation System - Class 1 Recall
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2014 Category: Medical Equipment Source Type: alerts
BREAKOUT CLEARING EMERGENCY SPOT FIX (Benzoyl Peroxide) Lotion [Dermalogica, Inc.]
Updated Date: Feb 18, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - February 18, 2014 Category: Drugs & Pharmacology 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 - Dash 3000/4000/5000 Patient Monitor - Class 2 Recall
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: 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 ...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
LEVONORGESTREL EMERGENCY CONTRACEPTIVE (Levonorgestrel) Tablet [Perrigo New York Inc]
Updated Date: Jan 15, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 15, 2014 Category: Drugs & Pharmacology Source Type: alerts
