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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- RAYSEARCH LABORATORIES AB
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1597-2021
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