RayStation 9A Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Under the severity rubric, an FDA Class II recall involving a medical device used for radiation therapy, where a software error could lead to incorrect treatment dosing, is categorized as Severe (Score 4).
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 9A software, identified by UDI # 07350002010174 and build number 9.0.0.113. The software is used for radiation therapy and medical oncology to administer treatments.
The recall is due to a software error identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms. This error could result in a local underestimation of the expected dose during treatment planning.
The affected software was distributed nationwide in the United States, including in Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana. Healthcare providers using this software should contact RaySearch Laboratories for further instructions on correcting the dose calculation algorithms.
The recalled product
- Product
- RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
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 (1)
- UDI # 07350002010174 Build number: 9.0.0.113
Distribution
Part of a larger recall action
This product is one of 15 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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