Toshiba Infinix X-Ray Interventional System INFX-8000V/UU.… recallZ-1714-2014 · Toshiba American Medical Systems Inc · initiated May 12, 2014
Class II Terminated All recalls posted in June 2014
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
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
FDA root cause category: Other
What the company is doing
Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail. The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form. Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.
Recall details
- Recall number
- Z-1714-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 12, 2014
- Posted by the FDA
- Jun 4, 2014
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 2
- Product code
- MQB
- FDA submissions
- K120073
- Distribution
- Nationwide Distribution including CA and IN
Product description
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Code information (models, lots, serial numbers)
Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
Other devices under the same FDA submission
1 device cleared under K120073 — 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.
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