FDA recall Z-2315-2018

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.

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.

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.

Key facts

Status

Terminated

Initiation date

2018-01-04

Report date

2018-07-04

Termination date

2023-10-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2315-2018