FDA Recall Open, Classified

RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 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 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI 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

Recall: Z-0732-2022 · Initiated December 30, 2021

Recall

Recall Number: Z-0732-2022
Event Number: 89631
Firm: RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
FEI Number: 3007774465
Product Code: MUJ
Status: Open, Classified
Root Cause: Software design
Initiated: December 30, 2021

Description

Reason

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

Action

RaySearch issued Field Safety Notice, Medical Device Correction #90375 via E-mail, on 30 December 2021. Letter stated reason for recall, health risk and action to take: Do not change the primary image set while the cine loop is running. " If the primary image set has been changed while the cine loop is running, restart RayStation/RayPlan to restore correct behavior. " 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. Solution. This issue is resolved in RayStation/RayPlan versions 10A and higher (subject to market clearance in somemarkets). If customers wish to continue using versions of RayStation/RayPlan 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. Please confirm that you have received this FSN. If you want to attach a signed reply form to the email, please fill in the below. You can also fax this form to Fax: +1-631-828-2137 (US only). For regulatory information, please contact [email protected].

Distribution

US Nationwide distribution.

Quantity

75 Licenses