Z-2269-2019Class II

SOMATOM Definition Edge, Model Number 10590000 -

Name: Z-2269-2019 SOMATOM Definition Edge, Model Number 10590000 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients... on 2019-07-03. FDA classified it as Class II and gives the reason as "Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort". 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-2269-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2019-08-14
Terminated: 2024-05-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Root cause tag: software
FDA root cause: Software design
Action: Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2269-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2268-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2269-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2270-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2271-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2272-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2273-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2274-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14

Product code JAK

K120579Class IISomatom Definition EdgeSiemens Medical Systems, Inc. / cleared 2012-05-23

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)