The Recall Desk
HighFDA (Devices)·Z-2039-2023·Announced 2023-07-05

RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

What this means for you

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 an FDA Class II medical device recall affecting critical radiation therapy treatment planning calculations. No injuries or illnesses have been reported. The hazard is serious given the medical context but is described in conditional terms, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RaySearch America is recalling RayStation radiation therapy treatment planning software, including 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, and 10.1). Five systems have been distributed in the United States, specifically in Arizona, California, Georgia, and Washington.

The recall is due to a software bug in the deep learning segmentation tool. When deep learning segmentation is followed by geometric functions such as Create Wall, Expand/Contract, or ROI algebra operations, the calculations are incorrect. This produces incorrect regions of interest (ROI) and incorrect dose statistics.

If clinical staff use the incorrect dose statistics to assess whether a radiation therapy plan is acceptable, they may approve an inappropriate plan for patient treatment. The error could result in a treatment plan that is either more conservative or more liberal than intended.

Users of affected systems should contact RaySearch America Inc immediately. Do not use the affected software versions for treatment planning until corrective action has been obtained.

The recalled product

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.
Manufacturer
RaySearch America Inc
Category
Medical Device — Radiation Therapy Treatment Planning Software
Hazard
Affected units
5

Distribution

Distributed in 4 states:

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