RaySearch Laboratories recalls RayStation software versions 8.0.0.6 to 10.1.0.613 for potential incorrect total dose displays during radiation therapy treatment planning. Users should verify dose tracking settings to avoid treatment errors.
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software due to a potential error in the 'Total dose' display when using multiple treatment plans. This could lead to incorrect dose calculations if not addressed, though the issue only affects certain software settings and users.
The software may show an incorrect total dose when multiple treatment plans are used in a single course. This mismatch could cause dose calculations to be inaccurate, but the issue only affects the 'Total dose' option and not other dose tracking features.
Radiation therapy treatment planners using RayStation software versions 8.0.0.6 through 10.1.0.613 are affected. Users who create multiple treatment plans may be at risk of incorrect dose calculations.
Check for software versions listed: 8.0.0.6, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, or 10.1.0.613. The issue only impacts users with the 'Total dose' option in Dose tracking.
Check your RayStation software version to see if it matches the listed versions (8.0.0.6 through 10.1.0.613).
No, the issue only affects the 'Total dose' display in specific scenarios and does not cause immediate harm. It may lead to incorrect dose calculations if not addressed.
The recall does not specify a software update. Users should verify their version and check if they need to adjust dose tracking settings.
Check your RayStation software version against the list: 8.0.0.6, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, or 10.1.0.613.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1598-2021 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1598-2021 from RaySearch Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
