RayStation 4-11B, and RayPlan 1, 2, 7-11B including some… recallZ-0850-2022 · RaySearch America Inc · initiated Feb 11, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from RaySearch America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0850-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2022
- Recalling firm
- RaySearch America Inc
- Quantity
- 653 (US 149, OUS 504)
- Product code
- MUJ
- FDA submissions
- K211867
- 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.
Product description
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
Code information (models, lots, serial numbers)
UDI # 07350002010020, 07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010426
Devices named in this recall
20 devices in the FDA device registry whose identifier appears in the recall's code information.
- RayStation 9Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment12 recalls0 reports
- RayStation 8.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 9B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 7Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 8.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 8.1.2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 11.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 6.2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 6.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 11.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 6.0Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment6 recalls0 reports
- RayStation 5.0.3Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment5 recalls0 reports
- RayStation 11BRaysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment5 recalls0 reports
- RayStation 11A SP2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment5 recalls0 reports
- RayStation 10B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment5 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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