The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0720-2017·Announced 2016-12-14

RayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error

RaySearch Laboratories is recalling RayStation 5.0 software due to a potential error in dose display on auxiliary CT images, which could result in incorrect treatment planning data.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 the hazard involves a risk-of-harm product (radiation therapy planning software) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

RaySearch Laboratories AB is recalling 540 units of RayStation 5.0 Radiation Therapy Treatment Planning System software. The recall is due to a software error that may cause the display of computed dose on auxiliary CT images to be incorrect when multiple patient cases are used. This error can occur if a CT image set with the same Frame of Reference exists in another case, leading to incorrect maximum dose positions, dynamic isodose lines, or dose grid values.

The affected software versions are Build No. 5.0.0.37, 5.0.1.11, or 5.0.2.35, with only version 5.0.2.35 distributed in the United States. The software was distributed nationwide in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX, and WA. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare providers using RayStation 5.0 should verify their software version and contact RaySearch Laboratories for instructions on how to resolve the issue. The error affects the display of dose values in patient views, including the upper left corner display in 2D views, which may be incorrect or missing. Users should ensure that treatment plans are reviewed and approved by the intended user before administration, as per standard practice for this software.

The recalled product

Product
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
540

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 (2)

  • Build No: "5.0.0.37
  • 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

See all →

Same hazard · software error

See all →

Similar recalls