Bebig Isotopentechnik Gmbh recalls SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- Recall date
- October 17, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0517-2024
- FDA classification
- Class II
- Brand / firm
- Bebig Isotopentechnik Gmbh
- Sold / distributed
- US: MD OUS: Germany
Why it was recalled
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
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