Device Recall Olympus

  • Modelo / Serial
    Serial Numbers: 2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252, 2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716, 2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040, 2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241, 2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216, 2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514, 2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746, 2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768, 2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479, 2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228, 2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098, 2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606, 2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120, 2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960, 2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574, 2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713, 2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783, 2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) and in Australia.
  • Descripción del producto
    Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
  • Manufacturer
  • 1 Event

Fabricante

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

36 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Versions 6.0 through 6.4
  • Clasificación del producto
  • 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
  • Modelo / Serial
    Versions 6.0 through 6.4.1 (excluding version 6.3.8)
  • Clasificación del producto
  • 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
  • Modelo / Serial
    catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
  • Clasificación del producto
  • 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
  • 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
  • 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
  • Modelo / Serial
    Serial numbers 11053P230001, 11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001, 11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001, 11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007, 11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007, 11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008, 11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003, 11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004, 11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004, 11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004, 11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004, 11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004, 11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002, 11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005, 11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005, 11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102, 25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102, 25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107, 25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103, 25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110, 25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105, 25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102, 25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107, 25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103, 25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108, 25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106, 25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105, 25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101, 25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106, 25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105, 25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110, 25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105, 25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110, 25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109, 26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104, 26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109, 26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107, 26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109, 26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105, 26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110, 26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105, 26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110, 26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108, 26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101, 26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106, 26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101, 26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102, 26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102, 26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108, 26917W23-109, 26917W23-110, and 26992W23-110.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Olympus Electrosurgical Unit. || The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.
  • Manufacturer
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