Z-1299-2022Class II

RayStation 11B

Name: Z-1299-2022 RayStation 11B
Creator: Raysearch Laboratories Ab
Published: 2022-06-10
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2022-06-10 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 11B on 2022-06-10. FDA classified it as Class II and gives the reason as "This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1299-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-10
Posted: 2022-06-28
Terminated: 2024-06-11
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 11B
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
FDA root cause: Under Investigation by firm
Action: The firm notified customers of the recall via email on June 10, 2022. The notice was titled "Field Safety Notice, Medical Device Correction #99834." Customers were given precautions and instructed on a workaround. The issue will be resolved in the next version of RayStation, scheduled for market release in June 2022, though this may be subject to market clearance.
Quantity in commerce: 26
Distribution: US Nationwide distribution in the states of NJ and TX.
Product codes and lots: UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-28

Product code MUJ

K220141Class IIRayStation 11BRaySearch Laboratories AB (PUBL) / cleared 2022-04-15

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)