Toshiba American Medical Systems Inc: 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.

Recall number

Z-2315-2018

Recalling firm

Toshiba American Medical Systems Inc

Product

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.

Status

Terminated

Initiated

2018-01-04

Posted

not on file

Terminated

2023-10-10

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.

Root cause

Software design

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.

Quantity

162 units total

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.

Lot, serial or model codes

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

510(k) numbers

["K163702"]

PMA numbers

not on file

Product code

IYN

Firm FEI

2020563

Firm city

Tustin

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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