Recalls / —

—#27032

Product

Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013522

Affected lot / code info

Model Number 7393114

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2002-10-11

Posted by FDA

2003-05-16

Terminated

2006-10-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.