The Recall Desk
HighFDA (Devices)·Z-1468-2020·Announced 2020-03-18

RayStation 9B Software Recalled for Pitch and Roll Correction Errors

RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.

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 involves a medical device with a defect that could lead to incorrect treatment planning parameters, representing a risk of harm where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling one unit of the RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system. The recall affects a single system distributed to the state of Tennessee. The product is identified by UDI 07350002010266.

The recall was initiated because there is a potential for erroneous propagation of current tabletop positions when applying pitch or roll corrections. Specifically, while pitch and roll corrections are not propagated, the presence of non-zero pitch or roll values causes the lateral, longitudinal, and vertical values to be calculated incorrectly.

No specific instructions for consumers are provided in the source text, but the recall is limited to the single identified system in the United States.

The recalled product

Product
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Software
Hazard
Affected units
1

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 07350002010266

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 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.

See all 7 products in this recall →

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

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Same hazard · software error

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