The Recall Desk
HighFDA (Devices)·Z-1467-2020·Announced 2020-03-18

RayStation 9A Software Recall for Pitch and Roll Correction Errors

RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.

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 risk of harm (incorrect position propagation) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

RaySearch Laboratories AB is recalling one unit of the RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system. The recall is limited to a single system distributed in Tennessee, identified by UDI 07350002010174.

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 corrections are not propagated, non-zero pitch or roll causes the lateral, longitudinal, and vertical values propagated to be incorrect.

No specific instructions for consumers are provided in the source text. The recall is classified as Class II by the FDA.

The recalled product

Product
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy 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 07350002010174

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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