Z-0907-2014Class II

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography...

Name: Z-0907-2014 Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-11-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-11-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology on 2013-11-15. FDA classified it as Class II and gives the reason as "During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B". 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-0907-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-15
Posted: 2014-02-03
Terminated: 2015-03-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Root cause tag: software
FDA root cause: Software design
Action: A recall notification letter, dated November 15, 2013, was sent to Users.
Quantity in commerce: 147
Distribution: Nationwide Distribution.
Product codes and lots: models 8098027, 7740769, 10430603, 10590000, with multiple serial numbers: 64789, 64492, 66767, 66649, 64067, 66182, 65364, 64673, 64419, 66518, 66243, 64368, 64081, 60398, 66929, 66327, 66146, 66188, 66355, 66467, 64860, 64342, 73579, 73813, 64179, 66498, 64172, 66433, 66572, 66768, 64790, 66193, 64270, 66503, 65013, 65014, 64821, 64337, 64734, 65036, 66455, 66451, 66928, 65403, 65597, 64770, 66964, 66924, 64082, 66151, 66911, 65576, 67017, 64481, 64694, 66844, 73366, 64430, 65302, 64624, 66458, 60124, 66667, 64913, 64834, 73642, 66618, 66396, 66473, 73499, 64194, 64455, 60121, 64260, 66183, 64536, 83056, 64478, 65044, 60331,64424, 73738,64103,64232,64299,66851,66404,64929,64591,83014, 64114, 66381, 60404, 67000, 66422, 64181, 66490, 66738, 65225, 64308, 66253, 64822, 64484, 66757, 66679, 66616, 83059, 66813, 64603, 73679, 66695, 66878, 65948, 65572, 66248, 64304, 83044, 73160, 64019, 66375, 66689, 60173, 73030, 73655, 64504, 73818, 66112, 64882, 65341, 64243, 64297, 64378, 66824, 64370, 64340, 66445, 73547, 66462, 66882, 73761, 66316, 64927, 66694, 66700, 64071, 66634, 64827.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0907-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code JAK

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)