Events

Retiro De Equipo (Recall) de Device Recall Olympus

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Integrated Medical Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73088
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0893-2016
  • Fecha de inicio del evento
    2016-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143127
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Endoscope, flexible - Product Code GCQ
  • Causa
    If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
  • Acción
    The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.

Device

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
    Gastroenterology-Urology Devices
  • 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
    Integrated Medical Systems Inc

Manufacturer

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