INFX-8000V Interventional Angiography System. CAT-880B… recallZ-1394-2015 · Toshiba American Medical Systems Inc · initiated Mar 11, 2015
Class II Terminated All recalls posted in April 2015
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
The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.
FDA root cause category: Device Design
What the company is doing
Toshiba sent a Urgent Medical Device Correction letter dated March 11, 2015, to all customers who purchased the CAT-880B catherization table for the Tosiba Infinix X-Ray Interventional System. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or email to [email protected]. Customers with questions 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-1394-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 11, 2015
- Posted by the FDA
- Apr 6, 2015
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 28 units
- Product code
- OWB
- FDA submissions
- K143225
- Distribution
- Nationwide Distribution
Product description
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
Code information (models, lots, serial numbers)
Serial No. U7E1462009, ACA1472001, UEB1352004, UFD1442017, AAA1492001, ACA1492002, ULD1412014, AHA1482001, UPB1372006, ULD1392013, U6A1472001, ULD1452016, UPB1352005, ULD1452015, UDE1352017, A4B1472002, U4A14X2001, UPB1342004, 99B1342133, 99B1342134, UFD1452018, UFD13X2015, UFD13X2016, UFD1362014, UUC1452012, A6A1492002, UUC13Z2011, AAA14X2002, A4A13Z2001.
Other devices under the same FDA submission
1 device cleared under K143225 — 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