Recall Z-1668-2014— 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) and using Stress Echo Feature. Ultrasound imaging system.. Reason: 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..
- 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) and using Stress Echo Feature. Ultrasound imaging system.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.