Recalls / —

—#72845

Product

SOMATOM Emotion 6. Computed tomography X-ray system

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K023687

Affected lot / code info

Model Numbers: 10165888, 10165977, and 10046789.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2008-08-05

Posted by FDA

2008-09-21

Terminated

2008-11-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #72845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.