FDA recall Z-1598-2021

RAYSEARCH LABORATORIES AB · Class II · device

Product

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

Reason for recall

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

Distribution

Domestic: TN

Key facts

Status: Terminated
Initiation date: 2021-04-07
Report date: 2021-05-26
Termination date: 2023-06-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1598-2021