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.
