Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 4/21/2021
Class II
PRODUCT
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Recall Number: Z-1427-2021
REASON
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB on 3/25/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 system
DISTRIBUTION
U.S. Nationwide