Model Tsx-301B Aquilion CT System

• 2 recalls, same reason

  • Terminated Z-1035-2012 FDA Not yet classified ·initiated 3 Jan 2012
  • Terminated Z-1034-2012 FDA Not yet classified ·initiated 3 Jan 2012

  The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.

• • Terminated Z-3195-2011 FDA Unclassified (pre-2012) ·initiated 22 Jun 2011

  Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr

• 2 recalls, same reason

  • Terminated Z-2895-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011
  • Terminated Z-2896-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011

  Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.

• • Terminated Z-1257-2011 FDA Unclassified (pre-2012) ·initiated 7 Sep 2010

  Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.

• • Terminated Z-1665-2011 FDA Unclassified (pre-2012) ·initiated 22 Jul 2010

  Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.

• • Terminated Z-0907-2010 FDA Unclassified (pre-2012) ·initiated 7 Jan 2010

  When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant enhancement and clinically useful images may not be obtained.

510(k) Number

K083282 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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