Z-0107-2016Class II

SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of...

Name: Z-0107-2016 SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-08-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-08-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients on 2015-08-18. FDA classified it as Class II and gives the reason as "Software and firmware bugs". 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-0107-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-18
Posted: 2015-10-06
Terminated: 2017-05-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software and firmware bugs
Root cause tag: software
FDA root cause: Software design
Action: Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner.
Quantity in commerce: 21
Distribution: Nationwide Distribution
Product codes and lots: Model Number of device- 10742326 with serial numbers: 75514 75512 75510 75454 75437 75500 75475 75481 75439 75450 75482 75460 75493 75476 75458 75467 75487 75478 75513 75515, and 75501.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0107-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-06

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)