Z-1721-2014Class II

Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems

Name: Z-1721-2014 Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-03-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-03-21 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer... on 2014-03-21. FDA classified it as Class II and gives the reason as "The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury". 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-1721-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-21
Posted: 2014-06-04
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: 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: The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem.
Quantity in commerce: 345
Distribution: US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
Product codes and lots: Material numbers: 10165977, 10045692 , and 10165888 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 29161 27229 29185 27415 27212 29364 29186 29165 29233 29182 27235 29338 29176 29376 27232 29181 27369 29295 27230 29198 27244 29286 29126 27338 29302 27231 27334 29394 29264 32141 32156 32159

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1721-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1721-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

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)