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  • Dispositivo 254
  • Fabricante 101
  • Evento 124969
  • Implante 0
WATER PHANTOM
  • Modelo / Serial
    Model Catalog: MT-DDA (Lot serial: 28112); Model Catalog: MT-100 (Lot serial: 27225); Model Catalog: MT-DDA (Lot serial: 27225); Model Catalog: MT-100 (Lot serial: 28112)
  • Descripción del producto
    water phantom depth dose apparatus
  • Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO
  • 1 Event
    • Retiro De Equipo (Recall) de WATER PHANTOM
VVideo-GlideScope GVL laryngoscopes, models GVL3, GVL4 and GVL5, manufactured by Verathon Medical...
  • Modelo / Serial
  • Manufacturer
    Verathon Medical ULC
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para VVideo-GlideScope GVL laryngoscopes, models GVL3, GVL4 and GVL5, manufactured by Verathon Medical ULC, Canada
Video laryngoscope GLIDESCOPE
  • Modelo / Serial
    reusable sheets references AVL2, AVL3, AVL4, AVL5, GVL3, GVL4, GVL5, specific serials.
  • Descripción del producto
    For intubation.
  • Manufacturer
    Verathon Medical
  • 1 Event
    • Alerta De Seguridad para Video laryngoscope GLIDESCOPE
Video laryngoscope GLIDESCOPE
  • Modelo / Serial
    AVL3, AVL4, AVL5, GVL3, GVL4 and GVL5, specific serial
  • Descripción del producto
    For intubation.
  • Manufacturer
    Verathon Medical
  • 1 Event
    • Alerta De Seguridad para Video laryngoscope GLIDESCOPE
Verathon~, maker of GlideScope video laryngoscopes
  • Modelo / Serial
    manufactured between December 2010 and August 2011, are compatible with the GVL (analog) GlideScope monitor (0570-0200/0231-0003) only. Glide5cope GVL 3 [part # / Serial Numbers}: 0574-0007 / MD10500 to MDl12387 GlideScope GVL 4 [part # / Serial Numbers}: 0574-0001 / LG105000 to LG112758 GlideScope GVL 5 [part # / Serial Numbers}: 0574-0030 / XL105000 to XL111798
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    GlideScope Video Laryngoscopes
  • Manufacturer
    Verathon Inc
  • 1 Event
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Verathon GlideScope GVL/AVL Reusable Video Laryngoscope Blades
  • Modelo / Serial
  • Manufacturer
    Verathon Medical (Canada) ULC
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Verathon GlideScope GVL/AVL Reusable Video Laryngoscope Blades
Verathon GlideScope GVL /AVL Reusable Video Laryngoscope Blades
  • Modelo / Serial
  • Manufacturer
    VERATHON MEDICAL (EUROPE) B.V.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Verathon GlideScope GVL /AVL Reusable Video Laryngoscope Blades
Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3
  • Modelo / Serial
    Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3Part Number( PN): 0574-0007Serial Number Range(SN) : MD131860 - MD151622GVL 4PN: 0574-0001SN: LG131995 - LG151773GVL 5PN: 0574-0030SN: XL131578 - XL151524AVL 20574-0118AC131852 - AC151510AVL 30574-0115AD131589 - AD151506AVL 40574-0116AE131587 - AE151558AVL 50574-0117AF131504 - AF151500ARTG Number: 235136
  • Manufacturer
    Verathon Medical Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3
Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades
  • Modelo / Serial
    Model: Models: GVL3, GVL4, GVL5, AVL2, AVL3, AVL4, AVL5, Affected: Selected serial number ranges
  • Manufacturer
    Verathon Medical (Canada) ULC
  • 1 Event
    • Retiro De Equipo (Recall) de Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades
Universal Rectangular Extension
  • Modelo / Serial
  • Descripción del producto
    Universal Rectangular Extension
  • Manufacturer
    Civco Medical Solutions
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Universal Rectangular Extension
ultrasound equipment - Aortascan scanners
  • Modelo / Serial
    BLADDER SCAN BVI9600 and AORTASCAN AMI9700
  • Descripción del producto
    In urology, post-void residual measurement, bladder wall thickness and bladder weight measurement. Envascular, measurement of the diameter of the aorta.
  • Manufacturer
    Verathon Medical
  • 1 Event
    • Alerta De Seguridad para ultrasound equipment - Aortascan scanners
TYPE-S EXTENSION
  • Modelo / Serial
    Model Catalog: 20-CFHN-SUB2-V (Lot serial: )
  • Descripción del producto
    Type-S Head Extension 20-CFHN-SUB2-V
  • Manufacturer
    MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAPY
  • 1 Event
    • Retiro De Equipo (Recall) de TYPE-S EXTENSION
The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5
  • Modelo / Serial
    Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.
  • Descripción del producto
    The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. || The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. || The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
  • Manufacturer
    Verathon, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5
the General Purpose Sensor
  • Modelo / Serial
  • Descripción del producto
    Ultrasonics - other ultrasonic therapeutic equipment
  • Manufacturer
    CIVICO Medical Solutions
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the General Purpose Sensor
Sunquest Laboratory versions 6.4.0 and later using Online Entry (OEM)
  • Modelo / Serial
  • Descripción del producto
    Sunquest Laboratory versions 6.4.0 and later using Online Entry (OEM)
  • Manufacturer
    Sunquest Information Systems
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Sunquest Laboratory versions 6.4.0 and later using Online Entry (OEM)
Sunquest Laboratory System.
  • Modelo / Serial
    Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
  • Descripción del producto
    Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. || The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Laboratory System.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
  • Modelo / Serial
    Version 6.3.0 and Later
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Sunquest Laboratory SMART and SMART Select
  • Modelo / Serial
    Version 6.4.2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select || Product Usage: for clinical use
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Laboratory SMART and SMART Select
Sunquest Laboratory LabAccess Results Workstation
  • Modelo / Serial
    Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
  • Descripción del producto
    Sunquest Laboratory LabAccess Results Workstation (LARS)
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Laboratory LabAccess Results Workstation
SUNQUEST LABORATORY - BLOOD BANK AND BLOOD DONOR
  • Modelo / Serial
    Model Catalog: SQ1-BLB-SY (Lot serial: Version 6.0.1); Model Catalog: SQ1-BLD-SY (Lot serial: Version 6.0.1); Model Catalog: SQ1-BLD-SY (Lot serial: Version 6.0.2); Model Catalog: SQ1-BLB-SY (Lot serial: Version 6.0.2)
  • Descripción del producto
    Sunquest Laboratory Blood Bank and Blood Donor
  • Manufacturer
    SUNQUEST INFORMATION SYSTEMS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SUNQUEST LABORATORY - BLOOD BANK AND BLOOD DONOR
SUNQUEST LABORATORY
  • Modelo / Serial
    Model Catalog: SQI-MIC-SY (Lot serial: VERSION 6.4.0)
  • Descripción del producto
    SUNQUEST LABORATORY
  • Manufacturer
    SUNQUEST INFORMATION SYSTEMS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SUNQUEST LABORATORY
SUNQUEST LABORATORY
  • Modelo / Serial
    Model Catalog: SQI-MIC-SY (Lot serial: UNKNOWN)
  • Descripción del producto
    SUNQUEST LABORATORY
  • Manufacturer
    SUNQUEST INFORMATION SYSTEMS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SUNQUEST LABORATORY
Sunquest Laboratory
  • Modelo / Serial
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia.
  • Descripción del producto
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. || Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: || 1) Autoverify results directly from analyzers and reference laboratories || 2) Track tubes and containers from order to final disposition || 3) Monitor key metrics such as turnaround time and utilization using management reports || 4) Produce pathology results with Structured Reports || 5) Suggest microbiology workups online according to defined SOPs and rules || 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools || 7) Any change to patient results (inquiry, reports) is logged and available for review
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Laboratory
Sunquest Encompass
  • Modelo / Serial
    versions 2.4 and later
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Bahamas.
  • Descripción del producto
    Sunquest Encompass || The reporting site is using the Encompass software in an acute patient care setting.
  • Manufacturer
    Sunquest Information Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Sunquest Encompass
Stat GlideScope GVL size 2
  • Modelo / Serial
  • Manufacturer
    Verathon Medical ULC
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Stat GlideScope GVL size 2
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