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Sources: EU EUDAMED, US FDA
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Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·September 23, 2011
Propaq LT vital signs monitor, Model 802LTRN
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·October 22, 2006
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code MWI·June 5, 2007
Philips Expression MR200 MRI Patient Monitoring System.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·October 22, 2014
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
FDA Recall
Terminated
·INNOKAS MEDICAL OY TARJUSOJANTIE 12 KEMPELE Finland·Product code MWI·December 3, 2014
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
FDA Recall
Terminated
·Philips North America Llc·Product code MWI·February 22, 2022
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.
FDA Recall
Terminated
·Philips North America, LLC·Product code MWI·February 20, 2020
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
FDA Recall
Terminated
·GE Medical Systems Information Technologies·Product code MWI·April 30, 2003
DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MWI·November 19, 2009
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·October 15, 2012
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
FDA Recall
Terminated
·Medrad Inc·Product code MWI·April 15, 2013
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MWI·October 1, 2019
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·October 19, 2015
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·August 3, 2018
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
FDA Recall
Terminated
·Philips North America, LLC·Product code MWI·June 18, 2020
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·November 21, 2013
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·December 4, 2013
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.
FDA Recall
Terminated
·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011
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