RAYSEARCH LABORATORIES AB: 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)

Recall number

Z-0589-2021

Recalling firm

RAYSEARCH LABORATORIES AB

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)

Status

Terminated

Initiated

2020-11-11

Posted

not on file

Terminated

2023-05-09

Reason

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

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

124

Distribution

US Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

K200569

PMA numbers

not on file

Product code

MUJ

Firm FEI

3007774465

Firm city

Stockholm

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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