Reported Apr 6, 2022 · Ongoing
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5…
RaySearch America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RaySearch America Inc · 350 5th Ave Ste 5000 · New York, NY · 10118-0110
Is this the product you have?
RayStation 4-11Band RayPlan 127-11B
- including some service packsRayStation 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
4.0.0.144.0.3.44.5.1.144.7.2.54.7.3.134.7.4.44.7.5.44.7.6.74.9.0.425.0.1.115.0.2.355.0.3.176.0.0.246.1.1.26.2.0.76.3.0.67.0.0.198.0.0.618.0.1.108.1.0.478.1.1.88.1.2.59.0.0.1139.1.0.9339.2.0.48310.0.0.115410.0.1.5210.1.0.61310.1.1.5411.0.0.95111.0.1.2911.0.3.116 or 12.0.0.932
- Lot codes and dates
UDI # 07350002010020073500020100130735000201008207350002010075073500020102420735000201006807350002010112073500020101360735000201012907350002010204073500020102350735000201017407350002010266073500020102970735000201030307350002010365073500020103100735000201047107350002010389073500020104330735000201044007350002010426
- Amount recalled
- 653 (US 149, OUS 504)
Where it was sold
Why it was recalled
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
This product could cause temporary or reversible health problems — stop using it.
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