Z-2453-2008

SOMATOM Emotion 16. Computed tomography X-ray system

Name: Z-2453-2008 SOMATOM Emotion 16. Computed tomography X-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-08-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Emotion 16. Computed tomography X-ray system on 2008-08-05. The reason FDA records is "Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2453-2008
Status: Terminated
Initiated: 2008-08-05
Posted: 2008-09-21
Terminated: 2008-11-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Emotion 16. Computed tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.
Quantity in commerce: 53 units
Distribution: Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI.
Product codes and lots: Model Numbers: 10165888, 10165977, and 10046789.

Product code JAK

K050297Class IISomatom Emotion 16Siemens Medical Solution, Inc. USA / cleared 2005-03-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)