30 results
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11ms
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Sources: EU EUDAMED, US FDA
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Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Recall
Terminated
·SA3, LLC·Product code OLR·February 21, 2022
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code NBW·January 29, 2004
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
FDA Recall
Terminated
·LMS Medical Systems Ltd·Product code HGM·January 11, 2005
Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·May 12, 2009
Philips Avalon Fetal Monitor FM20; Model Number: M2702A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·May 12, 2009
GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems.
FDA Recall
Terminated
·EUROTROL INC·Product code GGM·October 18, 2018
GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
FDA Recall
Terminated
·GE Medical Systems Information Technologies·Product code HGM·May 21, 2003
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.
FDA Recall
Terminated
·GE Healthcare It·Product code HGM·March 11, 2013
Bravo pH Monitoring System Receiver
FDA Recall
Terminated
·Medtronic Gastroenterology Urology·Product code FGM·February 6, 2004
Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008