Z-1598-2020Class II

RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0...

Name: Z-1598-2020 RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0...
Creator: Raysearch Laboratories Ab
Published: 2020-03-04
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-03-04 / Open, Classified / root cause: supplier

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a... on 2020-03-04. FDA classified it as Class II and gives the reason as "Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1598-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-04
Posted: 2020-03-26
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: Field Safety Notice, Medical Device Correction #56089 was emailed to customers on 3/4/20. ACTIONS TO BE TAKEN BY THE USER " Do not use Siemens Virtual Wedge fields outside the Siemens recommended specification. If a field outside the recommended specification with a virtual wedge is sent to the LINAC, the treatment machine console (console software versions 8 and higher) will display a warning message, for example Initial gap > 1 cm! Proceed (y/n)?, or The distance between the static jaw and the moving jaw is greater than 1 cm. Do you want to continue? (y/n). If this happens, select n to prevent the treatment machine from delivering the field. " In RayPhysics, use the wedge Field size limits parameters (Figure 3) to restrict the maximum allowed field size for a wedged field, see Setting wedge field size limits in RayPhysics on page6 below for details. " Verify through measurement at the LINAC that a wedged shape is delivered for the maximum field opening allowed by the Field size limits parameters for each wedge angle for Siemens Virtual Wedge before clinical use. 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 that you have read and understood this notice by replying to the notification email. This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation/RayPlan affected by this issue is in use to ensure effectiveness of the workaround. Thank you for your cooperation, and we apologize for any inconvenience. For regulatory information, please contact [email protected]
Quantity in commerce: 1389 licenses
Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
Product codes and lots: Systems with software versions: 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 , 4.7.6.7 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 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 or 9.1.0.933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1598-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1598-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code MUJ

K190387Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2019-06-19

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)