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.
This recall has been terminated (originally issued May 16, 2012).
- Recall Initiated
- April 25, 2012
- Posted
- May 16, 2012
- Terminated
- October 19, 2012
- Recall Number
- Z-1616-2012
- Quantity
- 45
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Serial numbers: 205730 205732 205523 205557 205721 205704 205747 205709 205685 205796 205751 205797 205771 205786 205795 205775 205785 205773 205783 205782 205791 205793 205789 205804 205873 205848 205821 205811 205840 205708 205909 206029 206072 205814 205977 205935 205971 206089 206120 205988 206112 206038 206087 205956 205937.
Root Cause
Software design
Action Taken
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.