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.
FDA Recall Z-2315-2018 · Posted None
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2018-01-04
Date Terminated2023-10-10
Product Quantity162 units total
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.
Firm 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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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