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Recall Observatory FDA recall evidence

Device product

Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

Z-1068-2013

November 14, 2012

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 64673
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1068-2013

Official wording

Reason: 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.

Code information: Serial No: 1CB1262006

Distribution pattern: Distributed in the state of MD.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software may detect an error and perform error