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
FDA Recall Z-0850-2022 · Posted None
Advertisement
Recalling FirmRaySearch America Inc
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2022-02-11
Product Quantity653 (US 149, OUS 504)
Reason for Recall
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
Firm Action
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement