Z-1281-2021Class II

RayCare 3B (3.1.0.60341) -

Name: Z-1281-2021 RayCare 3B (3.1.0.60341) -
Creator: Raysearch Laboratories Ab
Published: 2021-03-03
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-03-03 / Open, Classified / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care on 2021-03-03. FDA classified it as Class II and gives the reason as "Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later". 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-1281-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-03
Posted: 2021-03-19
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Root cause tag: software
FDA root cause: Software design
Action: Raysearch issued via E-mail on 03 March 2021, Field Safety Notice, Medical Device Correction #75198 letter stating reason for recall, health risk and action to take: RaySearch will check if the issue affects your system and apply the below solution. " Until the solution has been applied, be aware that the message body is missing from messages created in RayCare 2. " Confirm you have read and understood this notice by replying to the notification email. For regulatory information, please contact [email protected] SOLUTION This issue will be resolved by RaySearch staff using a support tool. Using the support tool, the message body will be restored to all messages in the currently used RayCare version.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-31	2021-03-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)