Z-1267-2015Class II

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography...

Name: Z-1267-2015 SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-02-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-02-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed... on 2015-02-06. FDA classified it as Class II and gives the reason as "Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of...". 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-1267-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-06
Posted: 2015-03-12
Terminated: 2015-08-31
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: 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: Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Advisory Notice dated February 6, 2015, to all customers via USPS Certified Mail. The notice identified the affected product, problem and actions to be taken.
Quantity in commerce: 12
Distribution: US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY.
Product codes and lots: Model number: 10742326, with serial numbers: 75454, 75464, 75437, 75475, 75481, 75439, 75450, 75460, 75476, 75458, 75467, 75478.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-12

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)