Events

Recall of Device Recall Aplio Iseries (i700, i800, i900)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80019
  • Event Risk Class
    Class 2
  • Event Number
    Z-2315-2018
  • Event Initiated Date
    2018-01-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164227
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    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.
  • Action
    Canon sent an Urgent - Medical Device Correction letter dated January 4, 2018. Customers were notified of the issue and informed that a modified firmware will be installed to correct the issue. When that modified firmware becomes available, the Toshiba service representative will contact customers to schedule an appointment to install the firmware. Until the modified firmware is installed, instructions were provided to confirm that the main power switch is sent to OFF, insert the power plug into the power outlet, and to set the main power switch to ON. The system should be operated according to the procedure described in section 9.1, Connection the Power Cable and Protective Grounding, in the operation manual. Additionally, customers were asked to complete and return the attached Customer Reply Form. For further questions, please call (714) 730-5000.

Device

Device Recall Aplio Iseries (i700, i800, i900)
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA