RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Reported: November 7, 2018 Initiated: September 21, 2018 #Z-0294-2019
Product Description
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Reason for Recall
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 110 units
- Distribution
- Nationwide
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 110 units.
Why was this product recalled? ▼
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0294-2019.
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