FDA recall Z-2426-2020

RAYSEARCH LABORATORIES AB · Class II · device

Product

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

Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.

Key facts

Status: Ongoing
Initiation date: 2020-05-26
Report date: 2020-07-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2426-2020