Jul

2023

FDA Recall: Software Bug Could Lead to More Liberal Plan Than Needed

Company: RaySearch America Inc
Date of Enforcement Report: 07/03/2023
Class II

PRODUCT

Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.

Recall Number:

Z-2039-2023

REASON:

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

RECALLING FIRM/MANUFACTURER:

RaySearch America Inc

VOLUME OF PRODUCT IN COMMERCE:

5 systems

DISTRIBUTION:

US: AZ, CA, GA & WA

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Bug Could Lead to More Liberal Plan Than Needed

Allison Pate

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