Z-0321-2009

Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is...

Name: Z-0321-2009 Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-09-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-09-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the... on 2008-09-03. The reason FDA records is "software error - does not allow protocol to properly synchronize with ECG triggers". 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-0321-2009
Status: Terminated
Initiated: 2008-09-03
Posted: 2009-01-05
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: software error - does not allow protocol to properly synchronize with ECG triggers
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
Quantity in commerce: 9 units
Distribution: Nationwide
Product codes and lots: Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298

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