Toshiba American Medical Systems Inc: Medical Device Recall in 2013 - (Recall #: Z-1104-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

Product Classification:

Class II

Date Initiated: December 11, 2012

Date Posted: April 24, 2013

Recall Number: Z-1104-2013

Event ID: 64693

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.

Status: Terminated

Product Quantity: 233 units

Code Information:

Item numbers: TUS-A300/Wl and TUS-A500/Wl

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated