Z-0589-2021Class II

RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service...

Name: Z-0589-2021 RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service...
Creator: Raysearch Laboratories Ab
Published: 2020-11-11
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-11-11 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also... on 2020-11-11. FDA classified it as Class II and gives the reason as "Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan...". 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-0589-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Posted: 2020-12-15
Terminated: 2023-05-09
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0)
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.
Root cause tag: software
FDA root cause: Software design
Action: On November 11, 2020, the firm issued Field Safety Notices to affected customers via email. Customers were informed of the affected versions and the product issue. ACTIONS TO BE TAKEN BY THE USER: " Always verify in the RayStation/RayPlan GUI that all relevant regions of interest (ROIs) are within the dose grid. " If using the treatment plan report for evaluation of clinical goal results, verify the percentage outside the dose grid (% outside grid) for each ROI in the RayStation/RayPlan GUI. " In the treatment plan report, be aware that the Couch pitch angle and Couch roll angle values for setup beams may be incorrect. " Use exported DICOM plans, not the treatment plan report, for transferring treatment parameters to the delivery system. " 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). " Confirm you have read and understood this notice by replying to the notification email. This issue will be resolved in the next version of RayStation and RayPlan, scheduled for market release in November 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation and RayPlan affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
Quantity in commerce: 124
Distribution: US Nationwide distribution.
Product codes and lots: Software version numbers: 4.0.0.14 , 4.0.3.4 , 4.5.1.14 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 ,; 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15

Product code MUJ

K200569Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2020-09-24

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)