Z-0119-2014Class II

Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

Name: Z-0119-2014 Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Creator: Toshiba American Medical Systems Inc
Published: 2013-08-05
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2013-08-05 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging on 2013-08-05. FDA classified it as Class II and gives the reason as "The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI...". 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-0119-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-05
Posted: 2013-10-30
Terminated: 2016-06-28
Recalling firm: Canon Medical Systems USA, Inc.
Product: Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly
Root cause tag: design
FDA root cause: Device Design
Action: Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to [email protected] Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.
Quantity in commerce: 17 (1352 Total)
Distribution: Nationwide Distribution including and US Territory Puerto Rico
Product codes and lots: Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30
Z-0120-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30
Z-0121-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30
Z-0122-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30

Product code IYN

K050380Class IIXario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C / cleared 2005-02-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)