The Recall Desk
HighFDA (Devices)·Z-0679-2019·Announced 2019-01-02

RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

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 software defect that could impact patient treatment accuracy (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

RaySearch Laboratories AB is recalling specific versions of RayStation software, including versions 3.5, 4.0, 4.5, 4.7, 5, 6, 7, and 8A. The recall involves 69 units distributed across 29 states, including Arizona, California, and Texas.

The recall is due to a defect where isocenter shifts when using dose tracking are incorrectly interpreted according to the DICOM patient coordinate system. This error affects the listed software versions.

The source text does not provide specific instructions for consumers or healthcare providers regarding immediate actions to take, nor does it report any specific injuries or illnesses associated with this defect.

The recalled product

Product
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
69

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 (20)

  • Software version number: 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 5.0.0.37
  • 5.0.1.11
  • 5.0.2.35
  • 6.0.0.24
  • 6.1.0.26

Distribution

Distributed in 30 states:

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

See all →

Same hazard · software defect

See all →