Z-2315-2018Class II

Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be...

Name: Z-2315-2018 Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be...
Creator: Toshiba American Medical Systems Inc
Published: 2018-01-04
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2018-01-04 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of 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... on 2018-01-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2315-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-04
Posted: 2018-06-29
Terminated: 2023-10-10
Recalling firm: Canon Medical Systems USA, 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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2315-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2315-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28

Product code IYN

K163702Class IIAplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation / cleared 2017-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)