FDA Device recall Z-0206-2024

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical inf…

• FDA Device
• Class II
• ongoing
• Published 2023-11-08

On 2023-11-08 the FDA classified a Class II recall of RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical inf… by Raysearch Laboratories Ab, citing an issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when….

Read the official FDA Device notice

Product

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)

Reason

An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2024%22

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