Z-0842-03

Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging

Name: Z-0842-03 Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging
Creator: Siemens Medical Solutions USA, Inc
Published: 2002-10-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2002-10-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging on 2002-10-11. The reason FDA records is "Perfusion CT is displaying a higher gray and color values than normal. A software problem". 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-0842-03
Status: Terminated
Initiated: 2002-10-11
Posted: 2003-05-16
Terminated: 2006-10-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Perfusion CT is displaying a higher gray and color values than normal. A software problem.
Root cause tag: software
FDA root cause: Other
Action: Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
Quantity in commerce: 1
Distribution: The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
Product codes and lots: Model Number 7393114

Product code KPS

K013522Class IISomatom P30 CT SystemsSiemens Medical Systems, Inc. / cleared 2001-11-07

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)