RayStation stand-alone software treatment planning system.… recallZ-0866-2020 · Raysearch Laboratories AB · initiated Dec 19, 2019

Why it was recalled

Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

FDA root cause category: Software design

What the company is doing

Field Safety Notice, Medical Device Correction #52889 #52672 #52971 dated 12/18/2019. ACTIONS TO BE TAKEN BY THE USER " i. Do not use the options Map ROI(s) or Map ROI(s) reversed, only available by right-clicking in the ROI list. Instead, use the Copy ROI geometries dialog available in the Structure Definition module or the Map ROIs dialog available in the Deformable Registration module. " ii. Be aware that the Elekta guard leaf setting from RayStation may be overridden by the R&V system or TCS. Contact the suppliers of your R&V system and TCS for more information. Scripting can be used to position the guard leaves according to the settings of the delivery system to avoid the overrides. " iii. Do not use the beam.GetSSD() scripting method. If needed in scripting, see RayCommunity. " iv. Do not use the SSD value displayed in the DRR in the plan report or exported DRR. Instead, use the SSD value displayed in the Beam data section of the plan report. Please educate planning staff and all users about these workarounds. 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 replying to the notification email. SOLUTION i. The Map ROI issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets). ii. The Elekta guard leaves issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets). iii. The SSD issue will be resolved in the next version of RayStation, scheduled for market release in December 2019 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation 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.

Recall details

Recall number

Z-0866-2020

Recall class

Class II

Status

Terminated

Initiated by the company

Dec 19, 2019

Posted by the FDA

Jan 27, 2020

Recalling firm

Raysearch Laboratories AB

Quantity

3114 Devices/Licenses

Product code

MUJ

FDA submissions

K190387

Distribution

US Nationwide distribution in states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, WI

Product description

RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.

Other devices under the same FDA submission

2 devices cleared under K190387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• RayStation 9

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  12 recalls0 reports
• RayStation 8.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports