FDA Device recall Z-2464-2023
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and s…
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and s… by Raysearch Laboratories Ab, citing an issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2464-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-17 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayCare software, include version number 5A, 5B, 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. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0
Reason
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
Identifiers
| code_info | Product name (build number) UDI-DI RayCare 5A (5.0.0.60390) 0735000201039620210524 RayCare 5A SP1 (5.0.1.60052) 0735000…Product name (build number) UDI-DI RayCare 5A (5.0.0.60390) 0735000201039620210524 RayCare 5A SP1 (5.0.1.60052) 0735000201046420220305 RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316 RayCare 5B SP2 (5.1.2.60028) 0735000201062420220613 RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027 RayCare 6A (6.0.0.60553) 0735000201056320220617 |
|---|
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-2464-2023%22
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