Z-0752-2016Class II

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

Name: Z-0752-2016 INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Creator: Toshiba American Medical Systems Inc
Published: 2015-08-14
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2015-08-14 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems on 2015-08-14. FDA classified it as Class II and gives the reason as "When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software...". 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-0752-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-14
Posted: 2016-02-09
Terminated: 2016-05-18
Recalling firm: Canon Medical Systems USA, Inc.
Product: INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.
Quantity in commerce: 4
Distribution: US Nationwide Distribution to OH and NY
Product codes and lots: Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0752-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0752-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09

Product code OWB

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)