Recall Z-1427-2021— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1427-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-25

Class II · Ongoing

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2021-03-25. It names one FDA 510(k) clearance: K200569. 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). Reason: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Ongoing
Initiated: 2021-03-25
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K200569 — RayStationRaySearch Laboratories AB (PUBL)·cleared 2020-09-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Reason for recall

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

Data sourced from openFDA. This site is unofficial and independent of the FDA.