Z-1933-2015Class II

SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray...

Name: Z-1933-2015 SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-06-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-06-04 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at... on 2015-06-04. FDA classified it as Class II and gives the reason as "A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1933-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-06-27
Terminated: 2017-03-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Root cause tag: design
FDA root cause: Device Design
Action: A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
Quantity in commerce: 40 total
Distribution: Nationwide Distribution.
Product codes and lots: model numbers: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1933-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1933-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-27
Z-1934-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-27

Product code JAK

K133424Class IISomatom Emotion 6 CT Systems, Somatom Emotion 16Siemens Medical Solutions USA, Inc. / cleared 2014-01-17

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)