Events

Retiro De Equipo (Recall) de Device Recall APLIO 500 TUSA500

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 Toshiba American 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
    77599
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2711-2017
  • Fecha de inicio del evento
    2017-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156750
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    When continuous trace method is used as the tracing method on spectral doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
  • Acción
    Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed to call 800-521-1968.

Device

Device Recall APLIO 500 TUSA500
  • Modelo / Serial
    Serial Numbers: AAC1652199, AAC1652200, AAC1652201, AAC1652202, AAC1652203, AAC1652204, AAC1652205, AAC1652206, AAC1652207, AAC1652208, AAC1662209, AAC1662210, AAC1662211, AAC1662212, AAC1662213, AAC1662214, AAC1662215, AAC1662216, AAC1662217, AAC1662218, AAC1662219, AAC1662220, AAC1662221, AAC1662222, AAC1662223, AAC1672224, AAC1672225, AAC1672226, AAC1672227, AAC1672228, AAC1672229, AAC1672230, AAC1672231, AAC1672232, AAC1672233, AAC1692234, AAC1692235, AAC1692236, AAC1692237, AAC1692238, AAC1692239, AAC1692240, AAC1692241, AAC1692242, AAC1692243, AAC1692244, AAC1692245, AAC1692246, AAC1692247, AAC1692248, AAC1692249, AAC1692250, AAC1692251, AAC1692252, AAC1692253, AAC16X2254, AAC16X2255, AAC16X2256, AAC16X2257, AAC16X2258, AAC16X2259, AAC16X2260, AAC16X2261, AAC16X2262, AAC16X2263, AAC16Y2264, AAC16Y2265, AAC16Y2266, AAC16Y2267, AAC16Y2268, AAC16Y2269, AAC16Y2270, AAC16Y2271, AAC16Y2272, AAC16Y2273, AAC16Y2275, AAC16Y2276, AAC16Y2278, AAC16Y2279, AAC16Y2280, AAC16Y2281, AAC16Y2282, AAC16Y2283, AAC16Y2284, AAC16Y2285, AAC16Y2286, AAC16Y2287, AAC16Y2288, AAC16Y2289, AAC16Y2290, AAC16Y2291, AAC16Y2292, AAC16Y2293, AAD16Z2297, AAD16Z2298, AAD16Z2299, AAD16Z2300, AAD16Z2301, AAD16Z2302, AAD16Z2308, AAD16Z2309, AAD16Z2310, AAD16Z2311, AAD16Z2312, AAD16Z2313, AAD16Z2314, AAD16Z2315, AAD16Z2316, AAD1712317, AAD1712318, AAD1712319, AAD1712320, AAD1712321, AAD1712322, AAA1652007, AAA1652008, AAA1652009, AAA1652010, AAA1652011, AAA1652012, AAA1652014, AAA1652015, AAA1652016, AAA1652017, AAA1652018, AAA1652019, AAA1652020, AAA1652021, AAA1652022, AAA1652023, AAA1652024, AAA1652025, AAA1662076, AAA1662077, AAA1662078, AAA1662079, AAA1662080, AAA1662081, AAA1662082, AAA1662083, AAA1662084, AAA1662085, AAA1662086, AAA1662087, AAA1662088, AAA1662090, AAA1662091, AAA1662092, AAA1662093, AAA1672105, AAA1672106, AAA1672107, AAA1672108, AAA1672109, AAA1672110, AAA1672111, AAA1672112, AAA1672113, AAA1672114, AAA1672116, AAA1672117, AAA1672118, AAA1672119, AAA1672120, AAA1672121, AAA1672122, AAA1672123, AAA1672124, AAA1672125, AAA1672126, AAA1672127, AAA1672128, AAA1672129, AAA1672130, AAA1672131, AAA1672132, AAA1672133, AAA1672134, AAA1672135, AAA1672137, AAA1672141, AAA1672143, AAA1672144, AAA1672145, AAA1682146, AAA1682147, AAA1682148, AAA1682149, AAA1682150, AAA1682151, AAA1682152, AAA1682153, AAA1682154, AAA1682155, AAA1682156, AAA1682157, AAA1682158, AAA1682159, AAA1682162, AAA1692171, AAA1692172, AAA1692173, AAA1692174, AAA1692175, AAA1692176, AAA1692178, AAA1692179, AAA1692180, AAA6172101, AAA16Z2006, AAA16Z2007, AAA16Z2008, AAA16Z2009, AAA16Z2010, AAA16Z2011, AAA16Z2012, AAA16Z2013, AAA16Z2014, AAA16Z2016, AAA16Z2017, AAA16Z2018, AAA16Z2019, AAA16Z2020, AAA16Z2021, AAA16Z2022, AAA16Z2023, AAA16Z2024, AAA16Z2025, AAA16Z2026, AAA16Z2027, AAA16Z2028, AAA16Z2029, AAA16Z2030, AAA1712031, AAA1712032, AAA1712033, AAA1712034, AAA1712035, AAA1712036, AAA1712037, AAA1712038, AAA1712039, AAA1712042, AAA1712043, AAA1712044, AAA1712045, AAA1722046, AAA1722047, AAA1722048, AAA1722049, AAA1722050, AAA1722051, AAA1722052, AAA1722053, AAA1722054, AAA1722055, AAA1722056, AAA1722057, AAA1722058, AAA1722059, AAA1722060, AAA1722062, AAA1722076, AAA1722084, AAA1722086, AAA1722087, AAA1722088, AAA1722089, AAA1722090, AAA1722091, AAA1722092, AAA1722093, AAA1722094, AAA1722095, AAA1722101, AAA1722102, AAA1722103, AAA1722104, AAA1722105, AAA1722106, AAA1722107, AAA1722108, AAA1722109, AAA1722110, AAA1722111, AAA1722112, AAA1722113, AAA1722114, AAA1722115, AAA1722116, AAA1722117, AAA1722118, AAA1722119, AAA1722120, AAA1722121, AAA1722122, AAA1722123, AAA1722124, AAA1722125, AAA1722126, AAA1722127, AAA1722128, AAA1722129, AAA1732136, AAA1732137, AAA1732138, AAA1732139, AAA1732140.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    APLIO 500 TUS-A500 || diagnostic ultrasound system
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA