Device Recall Aplio Iseries (i700, i800, i900)

  • Modèle / numéro de série
    Model No. TUS-AI700. TUS-AI800, TUS-AI900. Serial No. HNA1792011, HAB1732009, HNA1772007, HNA1772006, HAB1732023, HAB1732013, HAB1732016, HAB16Z2002, NJC17X2086, NJC17X2087, JHA16X2004, HAB1732027, HAB16Z2001, HAB16Z2002, NJB1762003, JHA1752022, HAB16Z2003, HAB16Z2004, JHA1752019, NJB1782050, HAB1742033, NJB1772031, HNA1792013, HNA1772008, JHA1752010, HAB1742035, HAB1742036, NJB1762001, NJB1782042, JHA1762034, HAB1732030, HAB16Z2005, HAB1732007, HAB1742034, HAB1742037, JHA1752024, NJB1772019, JHA1762029, JHA1762031, NJB1782061, HAB1732019, HNA1772001, HAB1712008, HAB1722011, HAB1712010, HAB1712009, HNA1792014, HAB1722012, HAB16Z2003, HAB1732017, HAB1732018, HAB1712006, HAB1732014, HAB1712007, HAB1732015, HAB1732021, HAB1732020, HAB1732025, JHA1762030, HAB1732029, HAB1732031, NJC17X2066, HNA1772002, NJB1782060, NJB1782043, NJB1762002, JHA16X2002, NJB1782057, NJB1782055, JHA1752021, NJB1782058, NJB1762006, NJB1782056, NJC17X2089, NJB1772023, NJB1782051, NJB1782052, NJB1782053, NJB1782054, HAB1732006, NJB1782062, NJB1782063, NJB1762004, NJB1762005, NJB1772022, JHA1752014, JHA1752016, JHA1752017, JHA1752018, HNA1792012, NJC17X2068, NJC17X2069, NJC17X2070, NJC17X2067, NJB1782046, NJB1782047, NJB1782048, NJB1782049, NJB1772039, NJB1782041, NJB1782045, NJC17X2083, NJC17X2084, NJC17X2081, NJC17X2079, NJC17X2080, NJC17X2082, NJC17X2076, NJC17X2077, NJC17X2078, NJB1772021, NJB1782044, JHA1752020, HNA1772005, NJB1782064, JHA1762032, HAB1732010, HAB1732008, NJB1782059, NJB1762008, NJB1762007, NJB1762009, NJB1772024, NJB1772014, NJB1772017, NJB1772018, NJB1772015, NJB1772016, NJB1772011, NJB1772012, NJB1772020, NJB1762010, NJB1772035, NJB1772036, NJB1772037, NJB1772038, NJB1772026, NJB1772027, NJB1772028, NJB1772030, NJB1772034, NJB1772025, NJB1772032, NJB1772013, JHA1762036, NJC17X2090, JHA1762033, HNA1772010, HNA1772009, NJB1772029, HNA1772004, HNA1772003, NJB1782065, NJC17X2071, NJB17822040, NJC17X2074, NJC17X2075, NJC17X2085, HAB1732026, JHA16X2007, HAB1732022, JHA1752023, JHA1762026, JHA1762025, HAB1732028, JHA16X2001, JHA16X2003, HAB1742011, HAB1742012, JHA16X2001, JHA16X2003, JHA1752004, JHA1752005, JHA1752006, JHA1752007, JHA1752008, JHA1752009, JHA1752010, JHA1752011, JHA1752012, JHA1752013, NJB1772033, NJC17X2072, NJC17X2073, NJC17X2088, HAB16Z2001, HAB16Z2004, HAB16Z2005, HAB1732024, HAB1732032, HNA1792015, HNB17X2016, HNB17X2017, HNB17X2018, HNB17X2019, HNB17X2020, HNB17X2021, HNB17X2022, HNB17X2023, HNB17X2024, HNB17X2025, HNB17X2026, HNB17X2027, HNB17X2028, HNB17X2029, HNB17X2030, JHA16X2002, JHA16X2005, JHA16X2006, JHA16X2008, JHA16X2009, JHA1752011, JHA1752012, JHA1752013, JHA1752015, JHA1762027, JHA1762028, JHA1762035, JHA1762037, JHA1762038, JHA1762039, HAB1742001, HAB1742002, JHA16X2001
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : CA, CO, DE, GA, HI, IA, ID, IL, IN, MD, MI, MN, MO, NC, ND, NV, OH, OR, PA, SC, SD, TN, TX, VA, WA, WV and WY.
  • Description du dispositif
    Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 || The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
  • Manufacturer
  • 1 Event

Fabricant

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