FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015
- Recall number
- Z-0162-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015
- Status
- Terminated
- Initiated
- 2004-09-28
- Posted
- 2004-11-03
- Terminated
- 2008-09-04
- Reason
- Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Root cause
- Other
- Action
- 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.
- Quantity
- 21 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Lot, serial or model codes
- Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084, 53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139, 53144, 53145, 53147, 53151, and 53154
- 510(k) numbers
- ["K013522"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28