RayCare 5B and 6A including service packs- An oncology… recallZ-0206-2024 · Raysearch Laboratories AB · initiated Sep 12, 2023
Class II Open, Classified All recalls posted in November 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Raysearch Laboratories AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Raysearch issued Field Safety Notice, Medical Device Correction #121600 via email on 9/12/23. Letter states reason for recall, health risk and action to take: Educate staff and all users to open configurable documents from the Documents workspace to avoid the issue. " Review all configured documents and consider reconfiguration in a way that will not trigger the issue. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. Solution This issue will be resolved in the next version of RayCare, scheduled for market release in December 2023 (RayCare 2024A) (subject to market clearance in some markets). If customers wish to continue using versions of RayCare affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact [email protected].
Recall details
- Recall number
- Z-0206-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2023
- Posted by the FDA
- Nov 1, 2023
- Recalling firm
- Raysearch Laboratories AB
- Quantity
- 2 sytems
- Product code
- MUJ
- FDA submissions
- K200487
- Distribution
- MD, TN
Product description
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)
Code information (models, lots, serial numbers)
UDI-DI: (1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316; (2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027; (3) RayCare 6A (6.0.0.60553) 0735000201056320220617
Other devices under the same FDA submission
1 device cleared under K200487 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RayCare 4.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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