MULTITRACE-4 NEONATAL (Trace Elements 4) Injection, Solution [American Regent, Inc.]
Updated Date: Sep 2, 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) - September 2, 2014 Category: Drugs & Pharmacology Source Type: alerts
Smiths Medical ASD, Inc. - Portex Endotracheal Tube Holders - Class 1 Recall
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2014 Category: Medical Equipment Source Type: alerts
Smiths Medical ASD, Inc. - Portex Endotracheal Tube Holders - Class 1 Recall
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2014 Category: Medical Equipment Source Type: alerts
Smiths Medical ASD, Inc. - Portex Endotracheal Tube Holders - Class 1 Recall
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2014 Category: Medical Equipment Source Type: alerts
Smiths Medical ASD, Inc. - Portex Endotracheal Tube Holders - Class 1 Recall
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2014 Category: Medical Equipment Source Type: alerts
Beevers Manufacturing & Supply, Inc. - Luma Wrap - Class 2 Recall
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor B650 - Class 2 Recall
GE Healthcare, CARESCAPE Monitor B650. Product Usage:The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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, cardiac output, ...
Source: Medical Device Recalls - July 25, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S Family Ultrasound Systems - Class 2 Recall
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Business Unit Ultrasound Mountain View, CA 94043 The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2014 Category: Medical Equipment Source Type: alerts
INO Therapeutics (dba Ikaria) - INOmax DSIR Delivery System - Class 2 Recall
INOmax DSIR, model 10007, Nitric Oxide Delivery System The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOmaxDS provides continuous integrated monitoring of inspired O2, NO2, and NO, and ...
Source: Medical Device Recalls - May 3, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON X700 Ultrasound Systems - Class 2 Recall
ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. Product Usage: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structu...
Source: Medical Device Recalls - April 25, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Ultrasound Vivid E9 - Class 2 Recall
GE Ultrasound Vivid E9 Product Usage: GE Vivid E9 Ultrasound System is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, and vascular). (Sourc...
Source: Medical Device Recalls - April 24, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe - Class 2 Recall
ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe. ACUSON P300 is the Siemens brand name for Esaote product 7348, for which Esaote has the 510k. Esaote is a Siemens OEM manufacturer. Siemens Medical Solutions USA, inc. 685 E. Middlfield Road Mountain View, CA 94043 USA Esaote Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac (adult and pediatric), Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Transvaginal, Pediatric, Intra...
Source: Medical Device Recalls - April 4, 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 bloo...
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, general...
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 (F...
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts
