FDAFDA · Food and drugs·Recall number Z-1714-2014
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.
Published June 11, 2014 · Recall initiated: May 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- Nationwide Distribution including CA and IN
- Lot
- Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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