Z-0721-2017Class II

RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System

Name: Z-0721-2017 RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System
Creator: Raysearch Laboratories Ab
Published: 2016-11-09
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2016-11-09 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning... on 2016-11-09. FDA classified it as Class II and gives the reason as "Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that...". 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-0721-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-09
Posted: 2016-12-08
Terminated: 2019-06-11
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
Root cause tag: software
FDA root cause: Software design
Action: Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).
Quantity in commerce: US: 66 units
Distribution: US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
Product codes and lots: Build numbers: 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, 5.0.0.37, 5.0.1.11 or 5.0.2.35

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0721-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07

Product code MUJ

K160093Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2016-04-08

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)