Events

Rappel de Device Recall APLIO 500 TUSA500

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Toshiba American Medical Systems Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77599
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2711-2017
  • Date de mise en oeuvre de l'événement
    2017-05-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156750
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    APLIO 500 TUS-A500 || diagnostic ultrasound system
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA