FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Sensation CT Systems
- Recall number
- Z-0797-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Sensation CT Systems
- Status
- Terminated
- Initiated
- 2006-03-17
- Posted
- 2006-04-26
- Terminated
- 2008-04-17
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 86
- Distribution
- Nationwide. Product was distributed to medical facilities in AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL IN, KS, KY, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TX, UT and WI.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- 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