Z-1930-2019Class II

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1...

Name: Z-1930-2019 RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1...
Creator: Raysearch Laboratories Ab
Published: 2017-11-20
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2017-11-20 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended... on 2017-11-20. FDA classified it as Class II and gives the reason as "When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1930-2019
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Posted: 2019-07-03
Terminated: 2023-08-08
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Root cause tag: software
FDA root cause: Software design
Action: RaySearch issued Field Safety Notice, Medical Device Correction #24138 via email on November 20th, 2017. The letter identifies the product, issue, health risk and action to take: Do not use a number of histories above 6 million for electron dose calculation. Inspect all commissioned electron beam models for any applicator calculated with greater than 6 million. Contact customer support if you have any further questions. Confirm you have read and understood this notice. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017. Educate planning staff and all users about this workaround.
Quantity in commerce: 744
Distribution: US Nationwide Distribution
Product codes and lots: Software versions: 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 and 6.2.0.7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1930-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1930-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03

Product code MUJ

K171536Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2017-06-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)