Xario Diagnostic Ultrasound System, Model Ssa-660A

• • Terminated Z-0119-2014 FDA Class II ·initiated 5 Aug 2013

  The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

• • Terminated Z-1173-2010 FDA Unclassified (pre-2012) ·initiated 12 Nov 2007

  Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

510(k) Number

K050380 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K051500 Active Cleared 17 Jun 2005

• Aplio Xg Diagnostic Ultrasound System Model Ssa-790A Version 4.0

  Class II

  FDA 510(k) K091295 Active Cleared 15 May 2009

• Real-Time Reconstruction System Model Tsxf-001A

  Class II

  FDA 510(k) K950972 Active Cleared 15 Apr 1996

• Qd Knee/Foot Coil, Model Mjqj-147A

  Class II

  FDA 510(k) K051763 Active Cleared 14 Jul 2005

• Ssa-390A/Power Vision 8000

  Class II

  FDA 510(k) K991858 Active Cleared 16 Jun 1999

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