Siemens Medical Solutions USA, Inc. Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Sonovista: 10133170, Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02
Products Sold
Sonovista: 10133170, Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02
Siemens Medical Solutions USA, Inc. is recalling Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3. due to Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara pri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.
Recommended Action
Per FDA guidance
Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026