Siemens Medical Solutions USA, Inc Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298
Products Sold
Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298
Siemens Medical Solutions USA, Inc is recalling Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system due to software error - does not allow protocol to properly synchronize with ECG triggers. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
software error - does not allow protocol to properly synchronize with ECG triggers
Recommended Action
Per FDA guidance
The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
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