RayStation software recall due to incorrect total dose display
RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.
What this means for you
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 is classified as FDA Class II, which typically corresponds to a High severity score when no hospitalizations or serious injuries are explicitly reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation standalone software radiation therapy treatment planning systems. The affected models include 8A, 8B, 9A, 9B, 10A, and 10B, including some service packs. The recall is limited to specific software versions: 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, and 10.1.0.613.
The recall is due to a software defect where the 'Total dose' display in Dose tracking may be incorrect when using more than one plan in a treatment course. There may be a mismatch between the fractions that appear as selected in the Treatment course list and the fractions included in the dose summation. This issue only affects RayTreat users and only the 'Total dose' option; 'Accumulation' and other options in Dose tracking are correct.
The recall is classified as Class II by the FDA. The distribution pattern is listed as Domestic: TN. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
- 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 (11)
- Software version number: 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
- 10.1.0.613
Distribution
Distributed in 1 state:
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