Z-0795-06

SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system

Name: Z-0795-06 SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-03-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-03-09 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system on 2006-03-09. The reason FDA records is "When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0795-06
Status: Terminated
Initiated: 2006-03-09
Posted: 2006-04-26
Terminated: 2006-07-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
FDA root cause: Other
Action: The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.
Quantity in commerce: 38 units
Distribution: Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
Product codes and lots: Sensation 40 model number 8874427 with serial numbers 57021, 57028, 57015, 57037, 57001, 57038, 57019 and Sensation 64 model number 8377520 with serial numbers 54219, 54508, 54060, 54436, 54482, 54437, 54188, 54407, 54154, 54051, 54422, 54530, 54528, 54056, 54445, 54480, 54489, 54556, 54560, 54418, 54463, 54016, 54534, 54404, 54064, 54488, 54269, 54416, 54529, 54305 and 54210

Product code JAK

K040665Class IISomatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. / cleared 2004-04-02

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)