FDA Device recall Z-2899-2020
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, plannin…
- FDA Device
- Class II
- ongoing
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, plannin… by Raysearch Laboratories Ab, citing when performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2899-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-29 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Reason
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
Identifiers
| code_info | Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621" |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2899-2020%22
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