Z-1275-2018Class II

Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37...

Name: Z-1275-2018 Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37...
Creator: Raysearch Laboratories Ab
Published: 2018-01-26
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2018-01-26 / Terminated / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2... on 2018-01-26. FDA classified it as Class II and gives the reason as "Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient". 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-1275-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Posted: 2018-03-29
Terminated: 2020-01-13
Recalling firm: RaySearch Laboratories AB (publ)
Product: Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 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 or 7.0.0.19 UDI: 0735000201006820171130
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Root cause tag: design
FDA root cause: Device Design
Action: On January 26, 2018 RaySearch Laboratories AB sent Field Safety Notice, Medical Device Correction #25955 to each customer via e-mail. Customers were advised of the following: be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended; do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam; please educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification via email, fax or by calling local support. Customers with questions were instructed to contact David Hedfors via e-mail at [email protected]
Quantity in commerce: 2484
Distribution: Nationwide
Product codes and lots: Software build numbers: 4.9.0.42, 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 or 7.0.0.19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1275-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1275-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-29

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)