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  • Dispositivo 1229
  • Fabricante 1229
  • Evento 1230
  • Implante 0
Zimmer Specific Knee, Hip and Nail Implants
  • Modelo / Serial
    Multiple affected item numbers are provided in the attached FSN.
  • Descripción del producto
    Prostheses, Joint, Hip, Femoral Component
  • Manufacturer
    Zimmer Biomet
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Ysio and Ysio MAX systems and Multix Fusion Analog , Multix Fusion Digital Portable , Multix Fusi...
  • Modelo / Serial
    Ysio (model number 10281013 or 10281163) Ysio MAX (model number 10762470) System Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059) Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042) Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042) Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042) FDA Update Codes: AXIOM Multix MT (model number 8395415 or 8395399 or 8395381) Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119
  • Descripción del producto
    Stationary basic diagnostic x-ray system, digital
  • Manufacturer
    SIEMENS
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
XVI R4.5 and R4.6 without iGuide®
  • Modelo / Serial
    XVI R4.5 and R4.6
  • Descripción del producto
    XVI, iGuide, image
  • Manufacturer
    Elekta Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-Ray System, MultiDiagnost Eleva
  • Modelo / Serial
    708034/708032/708036/708037 with the optional cable swivel.
  • Descripción del producto
    X-Ray System
  • Manufacturer
    Philips Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-ray system, diagnostic. Series 7600/7700 Mobile C-Arm,, Interconnect PO Cable
  • Modelo / Serial
    Series 7600/7700 Mobile C-Arm, Compact 7600/7700 Mobile C-Arm, Compact 7700 Plus Mobile C-Arm. Used with interconnect PO Cable part number: 00-452118-01 or 00-453118-01. Serial Number range: 2457-2632.
  • Descripción del producto
    X-ray system, diagnostic, fluoroscopic, general purpose, mobile, digital
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-Ray System, diagnostic. OEC Fluorostar
  • Modelo / Serial
    GE OEC Fluorostar 7900, software versions 02.08.01 - 02.08.08.
  • Descripción del producto
    X-Ray System, diagnostic, fluoroscopic, angiographic, mobile, digital
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Xray, MobileDiagnost wDR
  • Modelo / Serial
    All MobileDiagnost wDR
  • Descripción del producto
    MobileDiagnost wDR
  • Manufacturer
    Philips Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-ray , fluoroscopy systems, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Inn...
  • Modelo / Serial
    Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems
  • Descripción del producto
    X-ray , fluoroscopy systems
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X ray, digital acquisition systems direct digital radiography, DigitalDiagnost
  • Modelo / Serial
    DigitalDiagnost patient carriage with serial number range from 00 000 00 to 09000543.
  • Descripción del producto
    X ray, digital acquisition systems direct digital radiography,
  • Manufacturer
    Philips Medical Systems
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-Ray Diffraction Systems
  • Modelo / Serial
    Revolution XRD (X-Ray Diffraction) Systems All systems
  • Descripción del producto
    Diffractometers, X-Ray
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
X-Ray Angiography
  • Modelo / Serial
    Affected medical devices: AXIOM Artis MP / Artis dMP and Artis zee Multipurpose C-arm System. Material number: 5904468 17555365 and 1009413
  • Descripción del producto
    Imaging, X-Ray Angiography
  • Manufacturer
    SIEMENS
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Xper Flex Cardio Patient Monitoring System
  • Modelo / Serial
    All Flex Cardio devices, Revision C Model/Product Numbers: 453564634201, 453564534211, 453564621791, 453564621801, 860335 and 860338 Flex Cardio devices, Revisions A and B To assist in identifying affected devices, each affected device has at least one of the following numbers on the label on its back: Service #: 453564241901 and 453564483321
  • Descripción del producto
    Monitoring Systems, Physiologic
  • Manufacturer
    Philips Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
XiO Radiation Treatment Planning Systems
  • Modelo / Serial
    Sites affected will be those: 1. Running XiO Release 4.51 and higher, and 2. Using Elekta linacs, and 3. Using third party fixed wedges in combination with MLCs
  • Descripción del producto
    Radiation Treatment Planning System
  • Manufacturer
    Elekta Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Xcelerate Ceramic 4:1 Cutting Blocks.
  • Modelo / Serial
    SCORPIO: 8000-0003, 8000-0004, 8000-0005, 8000-0006, 8000-0007,8000- 0008,8000-0009,8000-0011,8000-0013 DURACON: 8000-7005, 8000-7010, 8000-7020, 8000-7030, 8000-7040,8000-7050,8000-7060 All lot numbers
  • Descripción del producto
    Cutting Blocks
  • Manufacturer
    Stryker Osteosynthesis
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Workstations, Radiotherapy, Planning. Advantage Workstation Servers
  • Modelo / Serial
    Advantage Workstation Servers (AWS): Software Version 2.0; Release Version 2.0-4.0
  • Descripción del producto
    Workstations, Radiotherapy, Planning
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Workstation software, READY View
  • Modelo / Serial
    READY View version 10.3.67 is affected; PR# 7130256 to AFSSAPS (reference 201205472)
  • Descripción del producto
    Workstation software, analyzing fMRI images
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Wheelchairs, Corpus Lowrider Chairs
  • Modelo / Serial
    Model: C500 Corpus LR; Article No.: 308370-99-1; Chasis product Nos.: (1) 308370-99-1, FOOTPL.BRACK LONG V.2 CII, (2) 104020-99-0, C500 R-NET WITH CORPUS-SEAT LOWRIDER, (3) 103968-99-0, C500 S-10 R-NET WITH CORPUS-SEAT LOWRIDER, (4) 102245-99-0, C500 7,5km/h WITH CORPUS-SEAT, (5) 102331-99-0, C500S 10km/h WITH CORPUS-SEAT LOWRIDER
  • Descripción del producto
    Wheelchairs, Powered
  • Manufacturer
    Permobil AB
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
WATCHMAN® Left Atrial Appendage Closure Device with
  • Modelo / Serial
    See attcahed file
  • Descripción del producto
    Filters, Blood
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Walking frame, wheeled
  • Modelo / Serial
    Walker Ono 15041201-14 up to serial no 223000
  • Descripción del producto
    Walker
  • Manufacturer
    Etac
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Walker (walking aid) , Crocodile
  • Modelo / Serial
    S/N : 86803 Model : Size 3
  • Descripción del producto
    Walker (walking aid) , Crocodile
  • Manufacturer
    R82 A/S
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
vP1.7 COLLEAGUE Pump.
  • Modelo / Serial
    Product Codes: vP1.7 COLLEAGUE Pump. (2M91617 and 2M91637) Serial numbers: All
  • Descripción del producto
    Infusion pump, general-purpose
  • Manufacturer
    Baxter Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
VOLISTA StandOP and TRIOP
  • Modelo / Serial
    All Getinge VOLISTA cupolas of model StandOP and TRIOP made until June 2017 equipped with keypad ARD568801560.
  • Descripción del producto
    Surgical Lights
  • Manufacturer
    MAQUET Inc.
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Vivid Ultrasound
  • Modelo / Serial
    - Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0. - Vivid S70/S60 with software version 201, revision 55.0 and 63.0. - Vivid S70N/S60N with software version 201, revision 63.0.
  • Descripción del producto
    Ultrasound
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Viva Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter...
  • Modelo / Serial
    Product Name: Viva XT CRT-D Models: DTBA1D4, DTBA1D1 Product Name: Viva S CRT-D Models: DTBB1D4, DTBB1D1 Product Name: Evera XT DR ICD Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1 Product Name: Evera S DR ICD Models: DDBC3D1, DDBC3D4 Product Name: Evera XT VR ICD Models: DVBB1D1, DVBB2D4 Serial Numbers: See attached
  • Descripción del producto
    Dual/ Single/ Triple -chamber implantable defibrillator
  • Manufacturer
    Medtronic SA
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
VITROS MicroWell Assays
  • Modelo / Serial
    VITROS Immunodiagnostic Products Folate Reagent Pack (10758750009237) : 1513266 VITROS Immunodiagnostic Products Free PSA Reagent Pack (10758750013517) : 6842845 VITROS Immunodiagnostic Products FSH Reagent Pack (10758750000302) : 1931922 VITROS Immunodiagnostic Products Prolactin Reagent Pack (10758750000111) : 1849793 VITROS Immunodiagnostic Products TSH Reagent Pack (10758750000227) : 1912997 ………………………. Swissmedic Update code: VITROS Immunodiagnostic Products NT-proBNP Reagent Pack (10758750002061) : 6802156 ………………………. FDA update codes: VITROS HBeAg Reagent, Cat. No 6801819 VITROS Anti-HBe Reagent Pack, Cat No. 6801816 All expired, in-date, and future lots released.
  • Descripción del producto
    IVDs
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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