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
Check against the official notice below — it lists the full affected range.
RaySearch America Inc. is recalling RayStation versions 4.0 through 5.0.3.1 and RayPlan versions 1, 2, and 7 through 11B due to a defect that may cause incorrect calculations of the source to skin or surface distance (SSD), potentially resulting in radiation dose errors during treatment planning. A total of 653 units were distributed nationwide across 48 U.S. states and Washington, D.C.
The recall affects devices with specific UDI numbers ranging from 07350002010020 through 07350002010440. The source record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
Reason for recall: Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. Distribution: US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI. Quantity: 653 (US 149, OUS 504) Lot/code info: UDI # 07350002010020, 07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010426
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.