Z-0019-2016Class II

SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of...

Name: Z-0019-2016 SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-08-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-08-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same... on 2015-08-14. FDA classified it as Class II and gives the reason as "software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in...". 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-0019-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-14
Posted: 2015-10-05
Terminated: 2016-12-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition Edge; intended 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 angles or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
Root cause tag: software
FDA root cause: Software design
Action: A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
Quantity in commerce: 113 total
Distribution: Nationwide Distribution.
Product codes and lots: Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0019-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0019-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05
Z-0020-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05
Z-0021-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05

Product code JAK

K143401Class IISOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. / cleared 2015-04-06

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)