Medical software recall: RayStation radiation therapy dose calculation errors
RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.
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 medical device recall involving radiation therapy planning software where incorrect SSD calculations could affect patient treatment accuracy. No illnesses or injuries have been reported in the source material, placing it at the maximum score of 3 per the rubric for theoretical hazards without reported harm.
Plain-English summary
RayStation and RayPlan are radiation therapy planning software systems used by healthcare facilities to plan cancer treatment. Affected versions range from RayStation 4.0 through version 12.0 and RayPlan versions 1, 2, and 7-11B. These versions contain an error in calculating the source-to-skin distance (SSD)—the distance between the radiation source and the patient's skin or body surface.
The incorrect SSD calculation may result in dose errors in radiation treatment plans. This means the software may specify an inaccurate radiation dose for patients' therapy.
A total of 653 units have been recalled, with 149 units distributed in the United States and 504 units distributed internationally. The US distribution covered all 50 states and Washington, D.C. The FDA classified this as a Class II medical device recall.
The recalled product
- Product
- RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2)…
- Manufacturer
- RaySearch America Inc
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 (20)
- UDI # 07350002010020
- 07350002010013
- 07350002010082
- 07350002010075
- 07350002010242
- 07350002010068
- 07350002010112
- 07350002010136
- 07350002010129
- 07350002010204
- 07350002010235
- 07350002010174
- 07350002010266
- 07350002010297
- 07350002010303
- 07350002010365
- 07350002010310
- 07350002010471
- 07350002010389
- 07350002010433
Distribution
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