Recall Z-1616-2012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.
| Date | May 16, 2012 (initiated Apr 25, 2012) |
| Status | Terminated |
| Reason | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. |
| Root cause | Software design |
| Action | A field corrective action was initiated on 04/25/2012 under Siemens update program US019/12/S in which a "Customer Safety Advisory Notice" was sent to all customers notifying them of the problem and the recommended actions to avoid potential risk. A follow-up field corrective action will be initiated in which the affected software will be updated in the field. |
| Quantity | 45 |
| Distribution | Worldwide Distribution -- USA, including the states of TX, NJ, GA and the countries of Germany, United Kingdom, Republic of Korea, Australia, Japan, Poland, Israel, Singapore, France and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111674 | ACUSON Siemens Medical Solutions USA, Inc., Jun 30, 2011 |