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.
This recall has been terminated (originally issued June 4, 2014).
- Recall Initiated
- May 12, 2014
- Posted
- June 4, 2014
- Terminated
- October 2, 2014
- Recall Number
- Z-1714-2014
- Quantity
- 2
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution including CA and IN
Lot / Code Info
Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
Root Cause
Other
Action Taken
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.