Z-1558-2016Class II

SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of...

Name: Z-1558-2016 SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-04-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-01 / 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 by computer reconstruction of x-ray... on 2016-04-01. FDA classified it as Class II and gives the reason as "The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or...". 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-1558-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Posted: 2016-04-22
Terminated: 2017-04-17
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 by computer reconstruction of x-ray transmission.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
Root cause tag: software
FDA root cause: Software design
Action: Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.
Quantity in commerce: 37 CTsystems
Distribution: US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
Product codes and lots: SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1558-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1558-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

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)