The Recall Desk
HighFDA (Devices)·Z-1464-2020·Announced 2020-03-18

RayStation 8B Software Recalled for Pitch and Roll Correction Errors

RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.

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 and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

RaySearch Laboratories AB is recalling one unit of the RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system. The recall affects a single system distributed to the state of Tennessee.

The recall is due to a potential for erroneous propagation of current tabletop positions when applying pitch or roll corrections. The source text notes that while pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal, and vertical values propagated to be incorrect.

This is an FDA Class II recall. No specific instructions for consumers are provided in the source text.

The recalled product

Product
RayStation/RayPlan 8B, Build Number 8.1.0.47, 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 07350002010129

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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