Z-1597-2021 Class II Terminated
FDA device recall Z-1597-2021 was initiated by RAYSEARCH LABORATORIES AB on February 22, 2021 and is designated Class II. 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… The recall status is terminated (terminated May 1, 2023). Affected quantity: 116 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- February 22, 2021
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 units
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
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.
Distribution Pattern
US Nationwide distribution.
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