RecallDepth

Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.

Company
Siemens Medical Solutions Usa, Inc
Recall Initiated
October 11, 2002
Posted
May 16, 2003
Terminated
October 3, 2006
Recall Number
Z-0842-03
Quantity
1
Firm Location
Malvern, PA

Reason for Recall

Perfusion CT is displaying a higher gray and color values than normal. A software problem.

Distribution

The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.

Lot / Code Info

Model Number 7393114

Root Cause

Other

Action Taken

Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.

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