Z-2206-2016Class II

RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation...

Name: Z-2206-2016 RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation...
Creator: Raysearch Laboratories Ab
Published: 2016-07-01
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2016-07-01 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed... on 2016-07-01. FDA classified it as Class II and gives the reason as "An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2206-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-07-15
Terminated: 2017-09-25
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.
FDA root cause: Under Investigation by firm
Action: RaySearch Laboratories AB sent Field Safety Notice/Medical Device Correction #11905 Letter (RSL-D-61-298, dated 7/1/2016) to end users via e-mail on 7/1/2016. The letter informs end users of the issue and provides actions to be taken by the users (work around).
Quantity in commerce: US: 170 units
Distribution: California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington
Product codes and lots: Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 and 5.0.2.35

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2206-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2206-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-15

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)