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Terminated

SOMATOM Emotion 6. Computed tomography X-ray system

FDA Recall Z-2452-2008 · Posted 2008-09-21

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-08-05
Date Terminated2008-11-07
Product Quantity53 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023687SOMATOM EMOTION 6 CT SYSTEMSSiemens Medical Systems, Inc. · 2002-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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