Model Tsx-101A/H/I Aquilion 32/64 Sp CT System

• • Terminated Z-0013-2016 FDA Class II ·initiated 8 May 2015

  If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

• • Terminated Z-1113-2014 FDA Class II ·initiated 1 Oct 2013

  Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.

• • Terminated Z-3221-2011 FDA Unclassified (pre-2012) ·initiated 8 Dec 2010

  There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.

• • Terminated Z-2204-2011 FDA Unclassified (pre-2012) ·initiated 9 Apr 2010

  The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).

• 4 recalls, same reason

  • Terminated Z-1169-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2009
  • Terminated Z-1166-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2009
  • Terminated Z-1168-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2009
  • Terminated Z-1167-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2009

  Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.

510(k) Number

K080211 ↗

FDA Product Code

JAK

Models / Variants

Tsx-101A

H

I Aquilion 32

64 Sp Ct System

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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