Siemens Medical Solutions USA, Inc - YSIO MAX - Class 2 Recall
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2016 Category: Medical Equipment Source Type: alerts
Carefusion 2200 Inc - Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM - Class 2 Recall
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2016 Category: Medical Equipment Source Type: alerts
Carefusion 2200 Inc - Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM - Class 2 Recall
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2016 Category: Medical Equipment Source Type: alerts
EMERGENCY FIRST AID EYEWASH PURIFIED WATER (Water) Liquid [Longbow First Aid Products Manufactory]
Updated Date: Sep 19, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 19, 2016 Category: Drugs & Pharmacology Source Type: alerts
Draeger Medical, Inc. - VentStar Oxylog 3000F - Class 1 Recall
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 5, 2016 Category: Medical Equipment Source Type: alerts
B-K Medical A/S - BK Medical ApS Ultrasound System Scanner - Class 2 Recall
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 4, 2016 Category: Medical Equipment Source Type: alerts
HAWS PERSONAL EMERGENCY EYEWASH - DUO PH NEUTRAL (Water) Liquid [Haws Corporation]
Updated Date: Jun 27, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 27, 2016 Category: Drugs & Pharmacology Source Type: alerts
HAWS PERSONAL EMERGENCY EYEWASH - DUO SALINE (Water) Liquid [Haws Corporation]
Updated Date: Jun 27, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 27, 2016 Category: Drugs & Pharmacology Source Type: alerts
PLUM EMERGENCY EYEWASH/EYEWASH DUO/EYEWASH SHOWER ISS USA (Water) Liquid [Plum A/S]
Updated Date: Jun 24, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2016 Category: Drugs & Pharmacology Source Type: alerts
PLUM PH NEUTRAL EMERGENCY EYEWASH/EMERGENCY EYEWASH DUO/EMERGENCY EYEWASH SHOWER ISS USA (Water) Liquid [Plum A/S]
Updated Date: Jun 24, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2016 Category: Drugs & Pharmacology Source Type: alerts
Physio-Control, Inc. - LIFEPAK15 monitor/defibrillator - Class 2 Recall
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrill...
Source: Medical Device Recalls - June 16, 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
PROACTIV PLUS EMERGENCY BLEMISH RELIEF (Benzoyl Peroxide) Cream [Guthy-Renker LLC]
Updated Date: Apr 4, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 4, 2016 Category: Drugs & Pharmacology Source Type: alerts
Siemens Medical Solutions USA, Inc - CIOS ALPHA - Class 2 Recall
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2016 Category: Medical Equipment Source Type: alerts
OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use
Patients and other users of the affected device are at risk for serious adverse health consequences, such as burns and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 29, 2016 Category: American Health Source Type: alerts
