Z-2708-2017Class II

XARIO 100 TUS-X100 diagnostic ultrasound system

Name: Z-2708-2017 XARIO 100 TUS-X100 diagnostic ultrasound system
Creator: Toshiba American Medical Systems Inc
Published: 2017-05-01
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-05-01 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of XARIO 100 TUS-X100 diagnostic ultrasound system on 2017-05-01. FDA classified it as Class II and gives the reason as "When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below". 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-2708-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Posted: 2017-07-10
Terminated: 2023-10-11
Recalling firm: Canon Medical Systems USA, Inc.
Product: XARIO 100 TUS-X100 diagnostic ultrasound system
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to [email protected]. Customers with questions were instructed to call 800-521-1968.
Quantity in commerce: 7 units
Distribution: Nationwide Distribution
Product codes and lots: Serial Numbers: W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, MXA1723097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2708-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2708-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2709-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2710-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2711-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2712-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

Product code IYN

K162187Class IIXario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation / cleared 2016-09-30

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)