Z-1521-2016Class II

Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge...

Name: Z-1521-2016 Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-03-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-03-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the... on 2016-03-02. FDA classified it as Class II and gives the reason as "Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast...". 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-1521-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-02
Posted: 2016-04-19
Terminated: 2016-12-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Root cause tag: software
FDA root cause: Software design
Action: Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge, which could possibly cause scan aborts, res cans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium. Siemens mailed certified as well as via email distribution a Customer Advisory Notice to their customers to inform them about corrective actions for bug-fixing the following systems running with software version VA44A_SP3a, VA44A_SP3b, VA44A_SP3c, correction of potential safety issues. The issues described will be corrected with software VA44_SP4, handled as update CT051/15/P. Following the installation of this update, the mentioned malfunctions will be corrected.
Quantity in commerce: 1096
Distribution: Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product codes and lots: Model Number: 10590000 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1521-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19
Z-1519-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19
Z-1520-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19
Z-1521-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)