Z-1247-2019Class II

SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model...

Name: Z-1247-2019 SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model...
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-02-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-02-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography... on 2019-02-14. FDA classified it as Class II and gives the reason as "Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube". 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-1247-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-14
Posted: 2019-05-03
Terminated: 2020-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436.
Quantity in commerce: 53 total units distributed in U.S.
Distribution: US Nationwide Distribution
Product codes and lots: Serial numbers of all affected models: 122022 100143 100107 83834 83746 83811 66649 122020 83801 122008 122029 83767 83852 100092 83798 100091 100112 100129 100136 83837 122023 83871 100117 100097 100099 122009 83763 83819 83752 83845 83846 83749 83847 100146 83786 83842 83775 100090 83796 83768 83859 100087 83826 83754 83790 122011 83824 100147 83810 83758 100140 100085 83808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1244-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1245-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1246-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1247-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code JAK

K103127Class IISomatom Definition asSiemens Medical Solutions USA, Inc. / cleared 2011-03-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)