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 Recall Z-1616-2012 · Posted 2012-05-16
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2012-04-25
Date Terminated2012-10-19
Product Quantity45
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.
Firm 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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.