Z-1104-2013Class II

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

Name: Z-1104-2013 Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic...
Creator: Toshiba American Medical Systems Inc
Published: 2012-12-11
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2012-12-11 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system on 2012-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1104-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-11
Posted: 2013-04-12
Terminated: 2014-04-10
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: design
FDA root cause: Device Design
Action: Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter.
Quantity in commerce: 233 units
Distribution: Nationwide Distribution.
Product codes and lots: Item numbers: TUS-A300/Wl and TUS-A500/Wl

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1104-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-12

Product code ITX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)