RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Reported: July 1, 2020 Initiated: May 26, 2020 #Z-2426-2020
Product Description
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Reason for Recall
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 12
- Distribution
- Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 12.
Why was this product recalled? ▼
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2426-2020.
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