Siemens Medical Solutions USA, Inc SOMATOM Sensation CT Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SOMATOM Sensation CT Systems
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Sensation 10 model number 7543015, Sensation 16 model number 7393114, Sensation 64 model number 8377520, and Sensation Open model number 8872017. Software versions CT2006A and CT2006G.
Products Sold
Sensation 10 model number 7543015, Sensation 16 model number 7393114, Sensation 64 model number 8377520, and Sensation Open model number 8872017. Software versions CT2006A and CT2006G.
Siemens Medical Solutions USA, Inc is recalling SOMATOM Sensation CT Systems due to Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ECG-gated s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ECG-gated scan protocols in the CT2006A and CT2006G software of their SOMATOM Sensation CT Systems.
Recommended Action
Per FDA guidance
Firm has issued an advisory letter (3/28/2006) to affected customers per Update Instructions CT008/06/S. This letter informs customers about the potential problem and provides instructions to avoid this issue. A Siemens Service Engineer will visit affected sites to hand-deliver this letter and to delete any affected scan protocols, which can then be replaced with default protocols or with new customized protocols.
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