Z-2138-2021Class II

RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in...

Name: Z-2138-2021 RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in...
Creator: Raysearch Laboratories Ab
Published: 2021-06-08
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-06-08 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI... on 2021-06-08. FDA classified it as Class II and gives the reason as "Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2138-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-08
Posted: 2021-07-23
Terminated: 2024-03-20
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
FDA root cause: Under Investigation by firm
Action: RaySearch issued Urgent Field Safety Notice, Medical Device Correction #80230 via email on 06/08/21. Letter states reason for recall, health risk and action to take: TO BE TAKEN BY THE USER " Do not create setup beams with the localization point as isocenter (option 2). " Always perform secondary verification of new treatment positions. RayTreat will notify the user when the treatment positions have been updated. " Always perform imaging before treating the patient. " Educate planning staff and all users about this workaround. " 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 RayStation, scheduled for market release in June 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation 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: 5 units
Distribution: US distribution to TN; and Belgium
Product codes and lots: Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code MUJ

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)