Recall Z-2315-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
| Date | Jan 4, 2018 |
| Status | Terminated |
| 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 acc |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 Toshibamedical Systems Corporation, May 30, 2017 |