SOMATOM CT System Sensation Open. Computed tomography x-ray system.
FDA Recall Z-0796-06 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.