RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Reported: July 10, 2019 Initiated: November 20, 2017 #Z-1930-2019
Product Description
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Reason for Recall
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 744
- Distribution
- US Nationwide Distribution
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 744.
Why was this product recalled? ▼
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1930-2019.
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