Z-2426-2020 Class II Ongoing
FDA device recall Z-2426-2020 was initiated by RAYSEARCH LABORATORIES AB on May 26, 2020 and is designated Class II. 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 pla… The recall status is ongoing. Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- May 26, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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.
Distribution Pattern
Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
Code Information
Software versions 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 and 9.2.0.483