Z-2464-2023Class II

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system...

Name: Z-2464-2023 RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system...
Creator: Raysearch Laboratories Ab
Published: 2023-07-17
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2023-07-17 / Open, Classified / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well... on 2023-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2464-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-17
Posted: 2023-08-25
Recalling firm: RaySearch Laboratories AB (publ)
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
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 1 install
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2464-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2464-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-25

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)