RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Ser

Recalled April 6, 2022 · FDA recall Z-0850-2022 · RaySearch America

Hazard

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. · FDA Class II

Units

653 (US 149, OUS 504)

Sold at

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.

Description

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

Product

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 versions: 4.0.0.14, 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932

Manufacturer(s)

RaySearch America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →