Z-1427-2021Class II

RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A...

Name: Z-1427-2021 RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A...
Creator: Raysearch Laboratories Ab
Published: 2021-03-25
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-03-25 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) on 2021-03-25. FDA classified it as Class II and gives the reason as "Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1427-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-25
Posted: 2021-04-15
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
FDA root cause: Under Investigation by firm
Action: On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.
Quantity in commerce: 1 system
Distribution: US Nationwide in the state of TN.
Product codes and lots: Software version: 9A, 9B, 10A, 10B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1427-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1427-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-15

Product code MUJ

K200569Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2020-09-24

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)