Acuson S2000 Diagnostic Ultrasound System

• • Terminated Z-2051-2011 FDA Unclassified (pre-2012) ·initiated 15 Mar 2011

  The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.

• • Terminated Z-1837-2011 FDA Unclassified (pre-2012) ·initiated 17 Aug 2010 ·on shared 510(k) K082142

  There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.

• 3 recalls, same reason

  • Terminated Z-1005-2011 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-1006-2011 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009 ·on shared 510(k) K082142
  • Terminated Z-1007-2011 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009 ·on shared 510(k) K082142

  ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

• • Terminated Z-1392-2011 FDA Unclassified (pre-2012) ·initiated 28 Aug 2009 ·on shared 510(k) K082142

  If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.

• • Terminated Z-1884-2011 FDA Unclassified (pre-2012) ·initiated 7 Apr 2009 ·on shared 510(k) K082142

  Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's esophagus.

• • Terminated Z-1900-2011 FDA Unclassified (pre-2012) ·initiated 14 Jan 2009 ·on shared 510(k) K082142

  The product has a software problem in which previous patient measurement data gets associated with another patient's image.

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

510(k) Number

K082142 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Siemens Acuson 2000 Ultrasound System with Abvs Transducer

  Class II

  FDA 510(k) K081148 Active Cleared 22 Dec 2008

• Modification to Acuson X300 Ultrasound System

  Class II

  FDA 510(k) K071036 Active Cleared 16 May 2007

• Acuson Antares Diagnostic Ultrasound System

  Class II

  FDA 510(k) K063803 Active Cleared 5 Jan 2007

• Siemens Diagnostic Ultrasound Systems

  Class II

  FDA 510(k) K072090 Active Cleared 14 Sep 2007

• Modification to Acuson X150 Ultrasound System

  Class II

  FDA 510(k) K081121 Active Cleared 4 Jun 2008

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K113179 Active Cleared 7 Dec 2011

See all devices from Siemens Medical Solutions USA, Inc., Ultrasound DI →