Z-0607-2017Class II

SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project...

Name: Z-0607-2017 SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-11-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-11-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional... on 2016-11-02. FDA classified it as Class II and gives the reason as "Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version...". 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-0607-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-02
Posted: 2016-11-17
Terminated: 2017-11-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471.
Quantity in commerce: 7 systems
Distribution: Nationwide distribution to MI, NY, CA, KY, ND, and NE.
Product codes and lots: Model Number: 1059000 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0607-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0606-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-17
Z-0607-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-17
Z-0608-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-17

Product code JAK

K152036Class IISOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. / cleared 2015-10-09

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)