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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation/RayPlan

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 Class 2 Device Recall RayStation/RayPlansee related information
Date Initiated by FirmMarch 04, 2020
Create DateMarch 26, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1598-2020
Recall Event ID 85255
510(K)NumberK190387 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation 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.
Code Information 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
FEI Number 3007774465
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionField 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 quality@raysearchlabs.com
Quantity in Commerce1389 licenses
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUJ
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