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Terminated

Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.

FDA Recall Z-0842-03 · Posted 2003-05-16

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2002-10-11
Date Terminated2006-10-03
Product Quantity1

Reason for Recall

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

Firm Action

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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013522SOMATOM P30 CT SYSTEMSSiemens Medical Systems, Inc. · 2001-11-07

Official Source

View FDA Recall →

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

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