Recall Z-2315-2018— Toshiba American Medical Systems Inc

Name: FDA recall Z-2315-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-04

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2018-01-04, terminated 2023-10-10. It names one FDA 510(k) clearance: K163702. 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: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2018-01-04
Terminated: 2023-10-10
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163702 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation·cleared 2017-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.