Z-0206-2024Class II

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and...

Name: Z-0206-2024 RayCare 5B and 6A including service packs- An oncology information system used to support workflows and...
Creator: Raysearch Laboratories Ab
Published: 2023-09-12
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2023-09-12 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning... on 2023-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0206-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-12
Posted: 2023-11-01
Recalling firm: RaySearch Laboratories AB (publ)
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)
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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: Under Investigation by firm
Action: 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].
Quantity in commerce: 2 sytems
Distribution: MD, TN
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-01

Product code MUJ

K200487Class IIRayCare 3.1RaySearch Laboratories AB (PUBL) / cleared 2020-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)