The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1750-2024·Announced 2024-05-08

RayStation Radiation Therapy System Recalled for Potential Dosing Error

RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.

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: This Class II recall involves a radiation therapy treatment planning system with a potential software defect affecting dose calculations. Although the defect could result in significant harm through incorrect radiation dose delivery, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, recalls with theoretical hazards and no reported harm are scored at most 3 (High).

Plain-English summary

RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems manufactured by RaySearch Laboratories AB are subject to a Class II FDA recall. Approximately 128 units of these medical devices have been distributed worldwide, including throughout the United States and to numerous countries internationally.

The systems contain a potential software defect that could cause source-to-surface distance (SSD) calculations to be too high. Source-to-surface distance is a critical parameter in radiation therapy treatment planning. If this calculation is incorrect, the system may generate inaccurate radiation dose recommendations for cancer patients.

No illnesses or injuries have been reported to the FDA in connection with this defect. Healthcare facilities using the affected RayStation versions should contact RaySearch Laboratories AB to obtain corrected software or information about remediation. Patients who received treatment with these systems should consult their radiation oncology team if they have concerns about their care.

The recalled product

Product
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Treatment Planning Software
Hazard
Affected units
128

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 (7)

  • UDI: 0735000201054920220616
  • 0735000201067920221007 and 0735000201073020230913
  • GTIN: 07350002010549
  • 07350002010679 and 07350002010730
  • Serial Numbers: 13.0.0.1547
  • 13.1.0.144 and 13.1.1.89
  • Expiration Date: 2028-10-05.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

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