Acuson

• • Terminated Z-0667-2017 FDA Class II ·initiated 7 Nov 2016

  Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.

• • Terminated Z-1592-2016 FDA Class II ·initiated 8 Apr 2016

  While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.

• • Terminated Z-0182-2016 FDA Class II ·initiated 7 Oct 2015

  Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.

• • Terminated Z-2783-2015 FDA Class II ·initiated 19 Aug 2015

  The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.

• • Terminated Z-1056-2015 FDA Class II ·initiated 12 Jan 2015

  The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.

• • Terminated Z-1668-2014 FDA Class II ·initiated 23 Apr 2014

  Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.

• • Terminated Z-1667-2014 FDA Class II ·initiated 23 Apr 2014

  Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.

• • Terminated Z-0824-2014 FDA Class II ·initiated 22 Dec 2013

  The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.

• • Terminated Z-0825-2014 FDA Class II ·initiated 22 Dec 2013

  The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.

• • Terminated Z-0052-2014 FDA Class II ·initiated 10 Jul 2013

  Software issue results in inaccurate 3D image may result in ablation in wrong location.

• • Terminated Z-1081-2013 FDA Class II ·initiated 28 Mar 2013

  When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.

• • Terminated Z-1584-2015 FDA Class II ·initiated 11 Jul 2012

  In certain situations, loss of post exercise images can occur in Stress Echo.

• • Terminated Z-1581-2015 FDA Class II ·initiated 11 May 2012 ·on shared 510(k) K123622

  In some cases, the system is unable to capture a clip or image during a routine scan.

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

1. 10 Jul 2013 Recall initiated FDA recalls Z-0052-2014
2. 22 Dec 2013 Recall initiated FDA recalls Z-0824-2014
3. 22 Dec 2013 Recall initiated FDA recalls Z-0825-2014
4. 23 Apr 2014 Recall initiated FDA recalls Z-1668-2014
5. 23 Apr 2014 Recall initiated FDA recalls Z-1667-2014
6. 12 Jan 2015 Recall initiated FDA recalls Z-1056-2015
7. 19 Aug 2015 Recall initiated FDA recalls Z-2783-2015
8. 7 Oct 2015 Recall initiated FDA recalls Z-0182-2016
9. 8 Apr 2016 Recall initiated FDA recalls Z-1592-2016
10. 7 Nov 2016 Recall initiated FDA recalls Z-0667-2017

4 earlier events are in the sections above.

510(k) Number

K123622 ↗

FDA product code

IYN

Device class

Class II

Regulation

21 CFR Part 892.1550

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

• INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD by RIMED LTD.
• Xario 200 Diagnostic Ultrasound System V6.0 by Toshiba Medical Systems
• EZONO 3000 by Life-Tech Intl., Inc.
• SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, by Medison America, Inc.
• APLIO ARTIDA, V3.2 by Toshiba America Medical Systems, In.C
• ARIETTA 50 by FUJIFILM HEALTHCARE CORPORATION
• Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System by Canon Medical Systems Corporation
• SONOS 2000, SONOS 2500 (M2406 A) by Hewlett-Packard Co.
• 6440 Ultrasound System by Esaote S.p.A.
• Clarius Ultrasound Scanner by CLARIUS MOBILE HEALTH CORP.

• Symbia Intevo Bold combination

  Class IIb

  CE/MDR

• Biograph Vision 600 Combination

  Class IIb

  CE/MDR

• CS-20-1 Uniform Phantom Combi

  Class IIb

  CE/MDR

• Biograph Vision Quadra Combination

  Class IIb

  CE/MDR

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