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Recall Observatory FDA recall evidence

Device 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.

Z-1714-2014

May 12, 2014

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 68363
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1714-2014

Official wording

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.

Code information: Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.

Distribution pattern: Nationwide Distribution including CA and IN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.