Z-0679-2019Class II

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and...

Name: Z-0679-2019 RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and...
Creator: Raysearch Laboratories Ab
Published: 2018-11-12
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2018-11-12 / Terminated

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, RayStation 7 and RayStation 8A on 2018-11-12. FDA classified it as Class II and gives the reason as "Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0679-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-12
Posted: 2019-07-05
Terminated: 2020-04-17
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
FDA root cause: Under Investigation by firm
Action: RayStation issued Field Safety Notice, Medical Device Correction #37483, on 11/12/18 via email, states issue, action to be taken and correction of software in Dec 2018.
Quantity in commerce: 69
Distribution: AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI
Product codes and lots: Software version number: 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 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 6.0.0.24 , 6.1.0.26, 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61 or 8.0.1.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0679-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code MUJ

K180379Class IIRayStation 7RaySearch Laboratories AB (PUBL) / cleared 2018-04-25

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)