RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10...
FDA Device Recall #Z-1597-2021 — Class II — February 22, 2021
Recall Summary
| Recall Number | Z-1597-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 22, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RAYSEARCH LABORATORIES AB |
| Location | Stockholm, N/A |
| Product Type | Devices |
| 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.
Lot / 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
Other Recalls from RAYSEARCH LABORATORIES AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1110-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1106-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1109-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1104-2026 | Class II | RayStation/RayPlan. Model/Catalog Numbers: 12.0... | Nov 28, 2025 |
| Z-1108-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.