Z-0929-2009

Somatom Definition AS, Model number 8098027. Computed tomography x-ray system

Name: Z-0929-2009 Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-12-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-12-09 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Somatom Definition AS, Model number 8098027. Computed tomography x-ray system on 2008-12-09. The reason FDA records is "possible improper installation of tilt transport lock/tilt limiter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0929-2009
Status: Terminated
Initiated: 2008-12-09
Posted: 2009-01-23
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: possible improper installation of tilt transport lock/tilt limiter
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed.
Quantity in commerce: 42 units
Distribution: Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.
Product codes and lots: Serial numbers: 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64081, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64111, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64166, 64168, 64169, 64170, 64171, 64172, 64177, 64179, 64180, and 64181.

Product code JAK

K081022Class IISomatom Definition, Model As/as+Siemens Medical Solutions USA, Inc. / cleared 2008-06-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)