Company: Multidata Systems International Corp.
Date of Enforcement Report: 11/28/01
Radiation Treatment Planning Decision Support System (DSS),
Recall # Z-0213-2.
The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients.
Multidata Systems International Corp., St. Louis, MO, by letter on 6/22/01. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and worldwide.