Z-2542-2016Class II

Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200

Name: Z-2542-2016 Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200
Creator: Toshiba American Medical Systems Inc
Published: 2016-08-04
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-08-04 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200 on 2016-08-04. FDA classified it as Class II and gives the reason as "Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2542-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Posted: 2016-08-16
Terminated: 2017-11-17
Recalling firm: Canon Medical Systems USA, Inc.
Product: Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction letter was sent to all customers to bring to attention a potential problem of transducer heating with your Xario Ultrasound System. The letter informs the customers that the surface of the acoustic lens of a transducer may become hot because of a software error. The error occurs when a transducer is disconnected, reconnected, or another transducer is selected. The letter informs the customers of error message and the corrective action. Customers are instructed to complete the attached form and fax it to (877) 349-3054 or [email protected]. Customer with any questions are instructed to call (714) 730-5000 or their Toshiba service representative at (800) 521-1968.
Quantity in commerce: 93 units
Distribution: US Distribution
Product codes and lots: 99B1422854 99B1422858 99B1422859 99B1422860 99B1422861 99B1422862 99B1422863 99B1433093 99B1433097 99B1433098 99B1433100 99B1443176 99B1443177 99B1443178 99B1443179 99B1443180 99B1453269 99B1453270 99B1453271 99B1453272 99B1453273 99B1453274 99B1453277 99B1453278 99B1453293 99B1453294 99B1453295 99B1453296 99B1453297 99B1453300 99B1453301 99B1453302 99B1453303 99B1453304 99B1463369 99B1463370 99B1463371 99B1463372 99B1463373 99B1463376 99B1463377 99B1463378 99B1463379 99B1463380 99B1493642 99B1493643 99B1493644 99B1493645 99B1493646 99B1493647 99B1493648 99B1493649 99B1493650 99B1493651 99B1493716 99B1493717 99B1493719 99B1493720 99C1554630 99C1554631 99C1554632 99C1554633 99C1554634 99C1554635 99C1564695 99C1564696 99C1564697 99C1564698 99C1564699 99C1564700 99C1564701 99C1564704 99C1574785 99C1574786 99C1574787 99C1574788 99C1574789 99C1574790 99C1574791 99C1574792 99C1574793 99C1574794 99C1574795 99C1574796 99C1574797 99C1574798 99C1574799 99B1422855 99B1422856 99B1422857 99B1433091 99B1433092 99B1433094 99B1433095 99B1433096 99B1433099 99B1453275 99B1453276 99B1493718 99C1524295 99C1564702 99C1564703

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code IYN

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)