RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7), RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6), RayStation/RayPlan 7 (7.0.0.19), RayStation/RayPlan 8A (8.0.0.61), RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) Software ve
Hazard
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
What You Should Do
Remedy
A field safety notice dated February 07, 2022 was issued via email on February 11, 2022 which includes work around instructions to make sure that the SSD value is correct. Identify affected product via software version number(s). Notify all users and acknowledge receipt of the notice. For more information contact quality@raysearchlabs.com.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs:
RayStation 4.0 (4.0.0.14) to
RayStation 5 Service Pack 2 (5.0.2.35),
RayStation 5 Service Pack 3 (5.0.3.17),
RayStation 6/Ray
- Brand
- RaySearch America Inc
- UPC
- UDI # 07350002010020, 07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010426
Units Affected
653 (US 149, OUS 504)