Z-2188-2016Class II

Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V...

Name: Z-2188-2016 Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V...
Creator: Toshiba American Medical Systems Inc
Published: 2016-02-24
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-02-24 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System on 2016-02-24. FDA classified it as Class II and gives the reason as "During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal...". 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-2188-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-07-18
Terminated: 2017-04-25
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968.
Quantity in commerce: 23
Distribution: US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
Product codes and lots: Model Number - XIDF-AWS801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2188-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2016	Class II	Terminated	FDA Mandated	2016-07-27	2016-07-18

Product code OWB

K150967Class IIXIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation / cleared 2015-06-18

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)