Devices

Device Recall Olympus

  • Modelo / Serial
    Serial Numbers: 2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458, 2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413, 2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694, 2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869, 2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697, 2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935, 2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687, 2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354, 2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176, 2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386, 2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738, 2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064, 2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316, 2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053, 2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067, 2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964, 2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374, 2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576, 2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) and in Australia.
  • Descripción del producto
    Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
  • Manufacturer
    Integrated Medical Systems Inc
  • 1 Event

Fabricante

Integrated Medical Systems Inc
  • Dirección del fabricante
    Integrated Medical Systems Inc, 3200 2nd Ave N, Birmingham AL 35222-1212
  • Empresa matriz del fabricante (2017)
    Integrated Medical Systems Inc.
  • Source
    USFDA

36 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Olympus ENDOEYE HD II Video Telescopes
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Olympus ENDOEYE HD II Video Telescopes || Models: || WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; || WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; || repair cable 10mm 0/30 deg., part number W7100603
  • Manufacturer
    Olympus Corporation of the Americas
Device Recall Olympus ImageManager
  • Modelo / Serial
    Versions 6.0 through 6.4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
  • Descripción del producto
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
  • Manufacturer
    Olympus America Inc.
Device Recall Olympus ImageManager Software
  • Modelo / Serial
    Versions 6.0 through 6.4.1 (excluding version 6.3.8)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
  • Descripción del producto
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) || Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
  • Manufacturer
    Olympus America Inc.
Device Recall Olympus Fluid Aspiration Set
  • Modelo / Serial
    catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
  • Descripción del producto
    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 || The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
  • Manufacturer
    Northgate Technologies, Inc.
Device Recall OLYMPUS ViziShot EBUS Aspiration Needle
  • Modelo / Serial
    Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
  • Descripción del producto
    OLYMPUS ViziShot EBUS Aspiration Needle || Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
  • Manufacturer
    Olympus America Inc.
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