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

• • Terminated Z-0122-2014 FDA Class II ·initiated 5 Aug 2013 ·on shared 510(k) K091295

  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-2981-2011 FDA Unclassified (pre-2012) ·initiated 2 Jun 2010 ·on shared 510(k) K091295

  Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K091295 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cstc-002A, Extended Field of View Software Option

  Class II

  FDA 510(k) K063241 Active Cleared 9 Nov 2006

• Famio Diagnostic Ultrasound Systems, Model Ssa-530A

  Class II

  FDA 510(k) K051500 Active Cleared 17 Jun 2005

• 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

• Sms-712NA

  Class II

  FDA 510(k) K903085 Active Cleared 5 Oct 1990

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