Z-0744-2017Class II

SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the...

Name: Z-0744-2017 SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-11-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-11-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray... on 2016-11-15. FDA classified it as Class II and gives the reason as "Software update that provides software and firmware bug-fixes to improve system performance". 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-0744-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Posted: 2016-12-12
Terminated: 2018-04-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition Edge System, x-ray, tomography, computed 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 update that provides software and firmware bug-fixes to improve system performance
Root cause tag: software
FDA root cause: Software Design Change
Action: Siemens mailed a Customer Information Letter to affected customers on November 21, 2016 informing them of software updates that would provide bug-fixes to improve system performance and stability for customers with SOMATOM Definition AS, Definition Edge and Definition Flash systems using Software versions VA48A_SP1 and VA48A_SP2. The update will remotely be pushed to their systems or customers will be contacted by one of Siemens service organization to arrange a date for installation of the update on site. Customers with questions were instructed to call 1-800-888-7436.
Quantity in commerce: 104 systems
Distribution: Nationwide Distribution
Product codes and lots: Model # 10590000 Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0744-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12
Z-0743-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12
Z-0744-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

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)