Z-2109-2017Class II

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

Name: Z-2109-2017 Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Creator: Toshiba American Medical Systems Inc
Published: 2017-02-01
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-02-01 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F on 2017-02-01. FDA classified it as Class II and gives the reason as "It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2109-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Posted: 2017-05-30
Terminated: 2018-06-06
Recalling firm: Canon Medical Systems USA, Inc.
Product: Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba Medical planned action to be taken to address the defect: CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. 3. The corrections are made free of charge to customers. 4. You complete this recall by September 30, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. For further questions, please call (800) 521-1968
Quantity in commerce: US - 70 systems
Distribution: US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
Product codes and lots: S/N : 8181622393

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2017	Class II	Terminated	FDA Mandated	2017-06-07	2017-05-30

Product code OWB

K152785Class IIXIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation / cleared 2015-11-25

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)