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    MOVE 78 Cold & Flu Kit

    FDA UDI
    TREND POWER LIMITED·00850031915053·MOVE 78 Cold & Flu Kit comprises of a Touchless...

    CENTRA

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 1, 2010

    Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). The data sheet is labeled in part: "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria system interfaces. The SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code MHX·March 24, 2011

    CELL-DYN RUBY ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 10, 2019

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·January 30, 2024

    BD NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 6, 2024

    NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 21, 2026

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·December 21, 2018

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·February 1, 2019

    HT50 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·February 22, 2012

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·June 3, 2020

    NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 14, 2026

    STERRAD 100S STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·March 17, 2010

    NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 21, 2026

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 29, 2019

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·April 26, 2019

    CARESCAPE B850

    FDA Adverse Event
    Malfunction ·CRITIKON DE MEXICO S. DE R.L. DE C.V.·Product code MHX·August 15, 2019

    VENTILATOR, CONTINUOUS, FACILITY USE

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·September 12, 2008

    INTRALASE FS2

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HNO·July 20, 2016

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·February 20, 2019