Toshiba American Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-2315-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: January 4, 2018
Date Posted: July 4, 2018
Recall Number: Z-2315-2018
Event ID: 80019
Reason for Recall:

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.

Status: Terminated
Product Quantity: 162 units total
Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated