RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A… recallZ-1597-2021 · Raysearch Laboratories AB · initiated Feb 22, 2021

Why it was recalled

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

FDA root cause category: Software design

What the company is doing

RaySearch issued Field Safety Notice, Medical Device Correction #74977 letter on 22 February 2021 via Email. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Manual Merge beams in the 3D-CRT module Scenario: When merging a beam B1 with other beams (e.g., B2 and B3) in the 3D-CRT module. Action: If the target beam B1 has a clinical dose before the merge, make sure that all the beamsto be merged (B2 and B3) also have a clinical dose computed with the same dose engine. " Scripting when using the action MergeBeamSegments Scenario: When running a script containing the action MergeBeamSegments as below: beam_set.MergeBeamSegments(TargetBeamName="B1", MergeBeamNames=["B2", "B3"]) Action: If the target beam B1 has a clinical dose before running the script, make sure that the beams to be merged (B2 and B3) also have a clinical dose computed with the same dose engine. " Automated breast planning Scenario: When creating a treatment plan in the Automated breast planning module, the generated breast plan has two beams: A1 and A2. Actions: 1. Change module to Plan optimization. 2. Invalidate the dose for both the A1 and A2 beams by changing a beam property that can easily be restored (e.g., change the couch angle from 0 to 1). 3. Set the beam property back to the intended value (e.g., set the couch angle back to 0 for both beams). 4. Compute final dose. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm that you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in May 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this notice, all users must maintain awareness of this notice.

Recall details

Recall number

Z-1597-2021

Status

Terminated

Initiated by the company

Feb 22, 2021

Recalling firm

Raysearch Laboratories AB

Quantity

116 units

Product code

MUJ

FDA submissions

K200569

Distribution

US Nationwide distribution.

Product description

RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system

Devices named in this recall

15 devices in the FDA device registry whose identifier appears in the recall's code information.

• RayStation 9

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  12 recalls0 reports
• RayStation 8.0.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  11 recalls0 reports
• RayStation 9B SP1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  11 recalls0 reports
• RayStation 10.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  10 recalls1 report
• RayStation 8.0

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  10 recalls0 reports
• RayStation 8.1.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 10.0

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 10.0.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 7

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 8.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 8.1.2

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 6.2

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  7 recalls0 reports
• RayStation 6.1.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  7 recalls0 reports
• RayStation 6.0

  Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment
  6 recalls0 reports
• RayStation 5.0.3

  Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment
  5 recalls0 reports