Z-0797-06

SOMATOM Sensation CT Systems

Name: Z-0797-06 SOMATOM Sensation CT Systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-03-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-03-17 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Sensation CT Systems on 2006-03-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0797-06
Status: Terminated
Initiated: 2006-03-17
Posted: 2006-04-26
Terminated: 2008-04-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Sensation CT Systems
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)