RAYSEARCH LABORATORIES AB Recall 87797
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
RAYSEARCH LABORATORIES AB Recall 87797 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1597-2021 |
| Event ID | 87797 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 116 units |
| Recall Reason | 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. |
| Device Classification | 20210526 |
| Device Code Info | 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 |
| Center Classification Date | 20210514 |
| Recall Initiation Date | 20210222 |
| Recalling Firm | RAYSEARCH LABORATORIES AB |
| Initial Notification | |
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