The Recall Desk
HighFDA (Devices)·Z-0589-2021·Announced 2020-12-23

RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

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 lead to incorrect treatment planning, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

RaySearch Laboratories AB is recalling specific versions of its RayStation and RayPlan software, including models 4 through 10A, due to two identified issues in the treatment plan report. The recall affects 124 units distributed nationwide in the United States.

The first issue involves potentially incorrect information regarding the percentage of a region of interest with a clinical goal that is outside the dose grid. The second issue, specific to RayStation and RayPlan 9B and 10A, involves potentially incorrect 6D couch angles. These errors could impact the accuracy of radiation treatment planning.

Healthcare providers and users of the affected software should verify their software versions against the list of affected model numbers and contact RaySearch Laboratories AB for further instructions on remediation.

The recalled product

Product
RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
124

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 numbers: 4.0.0.14
  • 4.0.3.4
  • 4.5.1.14
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 4.7.6.7
  • 4.9.0.42
  • 5.0.1.11
  • 5.0.2.35
  • 5.0.3.17
  • 6.0.0.24
  • 6.1.1.2
  • 6.2.0.7
  • 6.3.0.6
  • 7.0.0.19
  • 8.0.0.61
  • 8.0.1.10
  • 8.1.0.47

Distribution

Distributed nationwide across the United States.

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