Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084, 53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139, 53144, 53145, 53147, 53151, and 53154
Products Sold
Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084, 53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139, 53144, 53145, 53147, 53151, and 53154
Siemens Medical Solutions USA, Inc is recalling SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015 due to Calcium Scoring feature on this devices is not closing properly after patient's exams.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Calcium Scoring feature on this devices is not closing properly after patient's exams.
Recommended Action
Per FDA guidance
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
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