Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall affecting a safety-critical radiation therapy planning system. The software malfunction could result in inaccurate treatment measurements, but no illnesses or injuries have been reported. Per the rubric, high-risk products where injury has not yet been reported receive a score of 3.
Plain-English summary
SagiPlan 2.2 is a brachytherapy treatment planning system manufactured by Bebig Isotopentechnik GmbH. The software is used to plan and calculate radiation therapy treatments.
A software malfunction has been identified that may cause numerical values to be rounded. When values are rounded, the resulting treatment measurements may be inaccurate.
Two licenses of this software are distributed and in use in the United States. An additional 255 licenses are distributed internationally, primarily in Germany. This recall was issued by the FDA and assigned notice number Z-0517-2024 with a Class II classification.
The recalled product
- Product
- SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- Manufacturer
- Bebig Isotopentechnik Gmbh
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SagiPlan
- article # 1374-0600
- version 2.2
Distribution
Distributed in 1 state:
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