The Recall Desk
HighFDA (Devices)·Z-2138-2021·Announced 2021-08-04

RayStation radiation treatment planning system positioning error recall

RayStation versions 9A through 11A may set initial delivery positions incorrectly during setup beam localization. Five units are affected; no patient injuries reported.

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: FDA Class II recall of a radiation treatment planning system with a confirmed defect that sets treatment positions incorrectly. While the hazard is real and the device is critical to cancer therapy, no patient injuries or illnesses are reported in the source, limiting the classification to High rather than Severe.

Plain-English summary

RayStation is a radiation treatment planning system used in cancer therapy to plan and optimize radiation treatment for patients. Versions 9A, 9B, 9B SP1, 10A, 10A SP1, 10B, and 11A of RayStation, used in combination with RayCare, are subject to this recall. Five units have been identified with the defect, distributed to Tennessee in the U.S. and Belgium.

The recalled systems have a defect where initial delivery positions are set incorrectly when setup beams are positioned at the localization point. This positioning error in treatment planning could affect the accuracy of radiation therapy delivery if not detected and corrected.

Healthcare facilities and treatment planning centers using affected RayStation versions should contact RaySearch Laboratories AB or the FDA for updated software, patches, or additional verification procedures to ensure treatment plan accuracy. The manufacturer recommends verifying all treatment positions before clinical use. No patient injuries or illnesses have been reported in association with this defect at the time of recall.

The recalled product

Product
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
  • treatment-position-error
  • radiation-planning-defect

Distribution

Distributed in 1 state:

  • TN

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