Recall Z-1667-2014— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-04-23, terminated 2015-11-12. It names one FDA 510(k) clearance: K123622. Product: ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.. Reason: 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-23
- Terminated
- 2015-11-12
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.