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Class 2 Device Recall RaySearch |
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| Date Initiated by Firm |
February 22, 2021 |
| Create Date |
May 14, 2021 |
| Recall Status1 |
Terminated 3 on May 01, 2023 |
| Recall Number |
Z-1597-2021 |
| Recall Event ID |
87797 |
| 510(K)Number |
K200569
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| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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| Product |
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 |
| Code Information |
Build number: 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 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 UDI: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A RayStation 5 Service Pack 3 (5.0.3.17) UDI 07350002010020 RayStation 6/RayPlan 2 (6.0.0.24) UDI 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) UDI 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) UDI 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) UDI 07350002010242 RayStation/RayPlan 7 (7.0.0.19) UDI 07350002010068 RayStation/RayPlan 8A (8.0.0.61) UDI 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) UDI 07350002010136 RayStation/RayPlan 8B (8.1.0.47) UDI 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) UDI 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) UDI 07350002010235 RayStation/RayPlan 9A (9.0.0.113) UDI 07350002010174 RayStation/RayPlan 9B (9.1.0.933) UDI 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) UDI 07350002010297 RayStation/RayPlan 10A (10.0.0.1154) UDI 07350002010303 RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) UDI 07350002010365 RayStation/RayPlan 10B (10.1.0.613) UDI 07350002010310 |
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
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Manufacturer Reason
for Recall |
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.
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FDA Determined
Cause 2 |
Software design |
| Action |
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. |
| Quantity in Commerce |
116 units |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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