FDA-Device2018-07-04Class II
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.
Toshiba American Medical Systems Inc
Hazard
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.
Sold states
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.
Affected count
162 units total
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2315-2018Don't want to check this manually?
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