Company: Semens Medical Systems
Date of Enforcement Report: 7/31/02
Class: II

PRODUCT
SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology.
Recall # Z-1162-2.

REASON
Software anomalies that affect measurement and calculation data.

CODE
Units with software version 1.0 or 1.1.

RECALLING FIRM/MANUFACTURER
Siemens Medical Systems, Inc., Issaquah, WA, by letter dated January 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
260 units.

DISTRIBUTION
Nationwide.