Z-0380-2018Class II

RayStation

Name: Z-0380-2018 RayStation
Creator: Raysearch Laboratories Ab
Published: 2017-07-17
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2017-07-17 / Terminated / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit... on 2017-07-17. FDA classified it as Class II and gives the reason as "For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0380-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-17
Posted: 2018-01-17
Terminated: 2018-08-29
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Root cause tag: design
FDA root cause: Device Design
Action: Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected.
Quantity in commerce: 117 units
Distribution: US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Product codes and lots: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-16

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)