RayStation 9B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.
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: The recall involves a medical device used for radiation therapy where a software error could lead to underestimation of dose. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 9B Service Pack 1 (UDI # 07350002010297, Build number 9.2.0.483). The product 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.
The product 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. No specific number of affected units or reported injuries is stated in the source text.
The recalled product
- Product
- RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
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 # 07350002010297 Build number: 9.2.0.483
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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