BEUDAMED
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    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature

    FDA Recall
    Open, Classified ·Philips Electronics North America Corporation·Product code MHX·July 13, 2018

    Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility.

    FDA Recall
    Open, Classified ·Philips Electronics North America Corporation·Product code MHX·July 13, 2018

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    FDA Recall
    Open, Classified ·Envisiontec US Llc·Product code EBZ·January 20, 2022

    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code GBZ·September 29, 2023

    Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code GBZ·April 21, 2022

    Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

    FDA Recall
    Open, Classified ·Handpiece Headquarters·Product code EBZ·April 4, 2018