Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2452-2008

SOMATOM Emotion 6. Computed tomography X-ray system

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

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Emotion 6. Computed tomography X-ray system on . 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 , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2452-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
SOMATOM Emotion 6. 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.