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Terminated

SOMATOM CT System Emotion 16. Computed tomography x-ray system.

FDA Recall Z-0793-06 · Posted 2006-04-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2006-03-09
Date Terminated2006-07-19
Product Quantity5 units

Reason for Recall

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

Firm Action

The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.

Root Cause

Other

Distribution Pattern

Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050297SOMATOM EMOTION 16Siemens Medical Solution, Inc. USA · 2005-03-01

Official Source

View FDA Recall →

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

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