RayCare software, include version number 5A, 5B, 6A… recallZ-2464-2023 · Raysearch Laboratories AB · initiated Jul 17, 2023
Class II Open, Classified All recalls posted in August 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 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
FDA root cause category: Under Investigation by firm
What the company is doing
RaySearch issued Field Safety Notice, Medical Device Correction #119464 Letter via E-mail, on July 17, 2023. Letter states reason for recall, health risk and action to take: Manually verify the patient s medication list with respect to included substances when adding an new allergy to a medication substance. " Make sure to update all medications when activating a new version of the drug ingredients value set in the RayCare admin interface. " Educate staff and all users about the absence of a warning when adding a patient allergy. " Inspect your product and identify all installed units with the above software version number(s). " Confirm that you have read and understood this notice by replying to the notification email. SOLUTION This issue is resolved in the RayCare 2023B, market released in July 2023 (subject to market clearance in some markets) and future versions. 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-2464-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 17, 2023
- Posted by the FDA
- Aug 25, 2023
- Recalling firm
- Raysearch Laboratories AB
- Quantity
- 1 install
- Product code
- MUJ
- FDA submissions
- K200487
- Distribution
- US Nationwide distribution in the state of TN.
Product description
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
Code information (models, lots, serial numbers)
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
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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