RayStation (2020-05-17)

Starting date:

May 17, 2020

Posting date:

June 5, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73247

Last updated: 2020-06-05

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  Reason
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  Affected products

Affected Products

RayStation

Reason

This notice concerns an issue found with the proton Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms in RayStation 4, 4.5, 4.7, 5, 6, 7, 8A, 8B, 9A and 9B (including all service packs). The effect of the issue is that robustly optimized plans using tangential fields may exhibit hot spots in the vicinity of the patient surface/skin in the delivered dose. These hot spots would not be visible in dose calculated with the RayStation proton pencil beam dose engine.

The issue can also be relevant for robustness analysis, and dose tracking of non-robust optimized plans using tangential fields. This issue is relevant for any dose computed with the analytical pencil beam (PB) dose engine, and the non-clinical optimization dose of the Monte Carlo (MC) dose engine. The issue is not relevant for the clinical MC dose engine, which handles the tangential fields correctly.

Affected products