Recall Z-1281-2021— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1281-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-03

Class II · Ongoing

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2021-03-03. It names one FDA 510(k) clearance: K200487. Product: RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.. Reason: Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later.

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

510(k) clearances named in this recall

1 on FDA's record

K200487 — RayCare 3.1RaySearch Laboratories AB (PUBL)·cleared 2020-06-10

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

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

Reason for recall

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

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