Z-0971-2015Class II

SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by...

Name: Z-0971-2015 SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-12-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-12-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data... on 2014-12-03. FDA classified it as Class II and gives the reason as "Artifacts are found in acquired imaging on the SOMATOM Force". 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-0971-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2015-01-14
Terminated: 2015-04-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Artifacts are found in acquired imaging on the SOMATOM Force.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
Quantity in commerce: 7
Distribution: PA, MA, MN, SC, MD, and TX.
Product codes and lots: Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0971-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

Product code JAK

K133589Class IISomatom ForceSiemens Medical Solutions USA, Inc. / cleared 2014-04-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)