Recall Z-0850-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
RaySearch America Inc
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
| Date | Feb 11, 2022 |
| Status | Open, Classified |
| Reason | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. |
| Root cause | Under Investigation by 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 quality@raysearchlabs.com. |
| Quantity | 653 (US 149, OUS 504) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), Sep 8, 2021 |