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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

    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex Cardio FC2010 Rev C 453564621791 Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021 Xper Flex Cardio 2010 Rev D 453564669081 Xper Flex Cardio 2010 Rev D Russia 453564674581 Xper Flex Cardio FC2010 Rev E 453564845841 Xper Flex Cardio 2010 Rev E Russia 453564845881 Service numbers associated with FC2020: Xper Flex Cardio 2020 Rev A 453564241911 Xper Flex Cardio 2020 Rev B 453564483331 Flex Cardio FC2020 Rev C 453564621801 Xper Flex Cardio 2020 Rev D 453564675001 Xper Flex Cardio FC2020 Rev E 453564845861 Software version number: 1.5.19 and 1.6.8

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·March 29, 2021

    Welch Allyn Connex Spot Monitor

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code MWI·August 10, 2023

    McKesson Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Change Healthcare Cardiology Hemodynamics Software

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code MWI·May 22, 2025

    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

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    FDA Recall
    Open, Classified ·Infinium Medical, Inc·Product code MWI·May 31, 2019