BEUDAMED
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    BIPAP A40 PRO

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNT·February 22, 2024

    Therapy table PINOPRO electric

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·PINO Pharmazeutische Präparate GmbH·3 devices

    Therapy table PINOPRO hydraulic

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·PINO Pharmazeutische Präparate GmbH·2 devices

    QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OAE·September 21, 2023

    Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·December 16, 2020

    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·December 16, 2020

    VITAL SIGNS

    FDA Adverse Event
    Death ·PHYSIOCONTROL CORP.·Product code MHX·February 27, 1997

    Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    FDA Recall
    Terminated ·Philips North America Llc·Product code DSI·November 18, 2020

    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    FDA Recall
    Terminated ·Philips North America Llc·Product code DSI·November 18, 2020

    Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DRE·September 29, 2009

    Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DSI·August 31, 2010

    Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DSI·August 31, 2010

    Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 VM8 863066, 863068, 453564022081, 453564024461, 453564024481 The SureSigns VS3 vital signs monitor and 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. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MHX·June 10, 2011

    Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and 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. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DPS·June 10, 2011

    NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Prolinx GmbH

    Authorized representative
    🇩🇪 Germany·97 Manufacturers·1780 Devices