FDAFDA · Food and drugs·Recall number Z-1068-2013
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Published April 17, 2013 · Recall initiated: November 14, 2012
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
Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- Distributed in the state of MD.
- Lot
- Serial No: 1CB1262006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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