INFX-8000V Bi-Plane X-Ray Interventional System recallZ-0752-2016 · Toshiba American Medical Systems Inc · initiated Aug 14, 2015
Class II Terminated All recalls posted in February 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Toshiba American Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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".
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-0752-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 14, 2015
- Posted by the FDA
- Feb 9, 2016
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 4
- Product code
- OWB
- FDA submissions
- K120073, K133535, K143225, K152696
- Distribution
- US Nationwide Distribution to OH and NY
Product description
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Code information (models, lots, serial numbers)
Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Other devices under the same FDA submission
1 device cleared under K120073, K133535, K143225, K152696 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000VCanon Inc. · Interventional fluoroscopic x-ray system1 death3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page