Z-1815-2017Class II

Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for...

Name: Z-1815-2017 Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for...
Creator: Raysearch Laboratories Ab
Published: 2017-01-18
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2017-01-18 / Terminated / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation... on 2017-01-18. FDA classified it as Class II and gives the reason as "An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board...". 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-1815-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-18
Posted: 2017-04-12
Terminated: 2019-06-12
Recalling firm: RaySearch Laboratories AB (publ)
Product: Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
Root cause tag: design
FDA root cause: Device Design
Action: RaySearch Laboratories sent a Field Safety Notice dated January 18, 2017, to their customers via email. ACTIONS TO BE TAKEN BY THE USER include: 1) Verify the GPU settings on each of the Citrix XenApp servers according to the instructions in this section. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. The graphics boards that are verified for operation are listed in the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. 2) Check that displayed graphics board in the GPU Settings dialog is listed as verified for operation according to the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. The following figure shows an example of a correct installation. If the graphics board is not verified for operation according to the System Environment Guidelines, the installation is incorrect. In this case, disable GPU computation and contact RaySearch Support. 3) Check if "Citrix Systems Inc. Display Driver" is displayed instead of the graphics board name. If so, the Citrix XenApp installation is incorrect. If an incorrect installation of Citrix XenApp is detected: a. Set the Citrix XenApp server to maintenance mode or disable GPU computation on the erroneous server; b. Contact RaySearch Support for instructions on how to resolve the issue. Customers are advised to pass a copy of the safety notice and educate IT staff and all users that are members of the RayStation-Administration user group (or equivalent) about this (i.e., users with the permission to change GPU settings). 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 completing and returning the last page via email or fax to: [email protected], fax 888 501 7195.
Quantity in commerce: 741 units
Distribution: Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.
Product codes and lots: 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, 5.0.0.37, 5.0.1.11, 5.0.2.35

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

Product code MUJ

K160093Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2016-04-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)