Z-0692-2017Class II

SOMATOM Force, System x-ray, tomography, computed

Name: Z-0692-2017 SOMATOM Force, System x-ray, tomography, computed
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-10-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-10-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Force, System x-ray, tomography, computed on 2016-10-20. FDA classified it as Class II and gives the reason as "Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as...". 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-0692-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Posted: 2016-12-02
Terminated: 2017-05-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Force, System x-ray, tomography, computed
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.
Quantity in commerce: 48 units distributed in U.S.
Distribution: Nationwide Distribution.
Product codes and lots: Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0692-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0692-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-02

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)