Model Ssa-680A Xario Xg Diagnostic Ultrasound System, Version 1.00

• • Terminated Z-0120-2014 FDA Class II ·initiated 5 Aug 2013 ·on shared 510(k) K072918

  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-1997-2010 FDA Unclassified (pre-2012) ·initiated 5 Jan 2010

  Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG (

• • Terminated Z-1100-2010 FDA Unclassified (pre-2012) ·initiated 11 May 2009 ·on shared 510(k) K072918

  Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the PET-511 BTM multi-plane transesophageal transducer (TEE) may result in injury including perforation.

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

510(k) Number

K072918 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K844124 Active Cleared 7 Dec 1984

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• Aquilion ONE (TSX-305A/3) V7.3

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• Diagnostic Ultrasonic Transducer

  Class II

  FDA 510(k) K863364 Active Cleared 27 Feb 1987

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