Recall – Treatment plan report includes incorrect data

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 12/23/2020
Class II

PRODUCT

RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0).

Recall Number: Z-0589-2021

REASON

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 11/11/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

124

DISTRIBUTION

U.S. Nationwide