Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118...
FDA Recall #Z-1104-2013 — Class II — December 11, 2012
Product Description
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Reason for Recall
Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
233 units
Distribution
Nationwide Distribution.
Code Information
Item numbers: TUS-A300/Wl and TUS-A500/Wl
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated