Company: Siemens Medical Systems, Inc
Date of Enforcement Report: 10/23/02
Class: III

PRODUCT
Somatom Sensation 16 systems.
Software upgrade from Somaris/5 VA50A to VA50B.
Recall # Z-0109-3.

REASON
Scans may be aborted if scans are started manually.

CODE
Model Number 7393114.
Four serial numbers 50012, 50022, 50025, 50029.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in July 2002.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4.

DISTRIBUTION
OH, NC and MA.