Z-0849-2022Class II

RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14...

Name: Z-0849-2022 RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14...
Creator: Raysearch Laboratories Ab
Published: 2021-09-22
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-09-22 / Open, Classified / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4... on 2021-09-22. FDA classified it as Class II and gives the reason as "An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0849-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-22
Posted: 2022-03-31
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 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, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
Root cause tag: design
FDA root cause: Device Design
Action: RaySearch issued Field Safety Notice, Medical Device Correction #84236 via E-mail on 22 September 2021. Letter states reason for recall, health risk and action to take: " Use the automatic tool in RayStation/RayPlan to create the External ROI. " When using a Support or Fixation ROI of tissue-like material (density around 1), extend this ROI a few millimeters inside the External ROI to cover the surface voxels of the patient. " If the Support or Fixation ROI differs significantly from the adjacent body tissue, an extra help ROI with material override set to a suitable material, for example, Skin, can be created inside the External ROI. The help ROI must have a width of a few millimeters and extend along the part of the patient surface connected to the Support or Fixation ROI. The same workflow can be used for Bolus ROIs in combination with electron beams. " If the bolus/support/fixation device is part of the CT data, an alternative solution is to include its structure inside the External ROI. In this case the structure should not be defined as a Bolus, Support or Fixation ROI, but as a normal ROI, by setting the ROI type to, for example Other . When included in the External ROI, the user can choose to use the CT densities or to apply a material override to the structure. If this method is applied for a bolus, the user must make sure that only the applicable beams pass through the structure. " For protons and light ions, the user should consider using a higher density uncertainty than normal in robust optimization for active scanning techniques and larger proximal and distal margins for the target in passive techniques, when shooting through a Fixation or Support ROI. " 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
Quantity in commerce: 478 licenses US
Distribution: US Nationwide.
Product codes and lots: Product name (build number) UDI-DI RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A RayStation 5 Service Pack 3 (5.0.3.17) 07350002010020 RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297 RayStation/RayPlan 10A (10.0.0.1154) 07350002010303 RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) 07350002010365 RayStation/RayPlan 10B (10.1.0.613) 07350002010310 RayStation 11A (11.0.0.951) 07350002010389 RayStation 11A Service Pack 1 (11.0.1.29) 07350002010433

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0849-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0849-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code MUJ

K211867Class IIRayStation 11.0RaySearch Laboratories AB (PUBL) / cleared 2021-09-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)