—#109121

Product

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111674
Affected 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-04-25
Posted by FDA: 2012-05-16
Terminated: 2012-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.