Company: Bebig Isotopentechnik Gmbh
Date of Enforcement Report: 12/08/2023
Class II
PRODUCT
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Recall Number:
Z-0517-2024
REASON:
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
RECALLING FIRM/MANUFACTURER:
Bebig Isotopentechnik Gmbh
VOLUME OF PRODUCT IN COMMERCE:
2 software licenses in US, 255 software licenses in OUS
DISTRIBUTION:
US: MD OUS: Germany
