FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: 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.
- Recall number
- Z-1714-2014
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-05-12
- Posted
- 2014-06-04
- Terminated
- 2014-10-02
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2
- Distribution
- Nationwide Distribution including CA and IN
- Lot, serial or model codes
- Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
- 510(k) numbers
- K120073
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28