Z-0713-2018Class II

SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628

Name: Z-0713-2018 SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-10-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-10-02 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of... on 2017-10-02. FDA classified it as Class II and gives the reason as "The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0713-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-02
Posted: 2018-02-24
Terminated: 2018-09-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent a Customer Safety Advisory Notice letter date October 2, 2017 to their customers. Customers were instructed not to use the table if there is any unusual noise or vibration and to contact Siemens service organization immediately at 1-800-888-7436. Customers were informed that a service technician will schedule an on site repair.
Quantity in commerce: 6
Distribution: US Nationwide Distribution in the states of FL, MO, NY, TN
Product codes and lots: Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0713-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0713-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0714-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code JAK

K163296Class IISOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. / cleared 2017-03-21

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)