device recall
saveElekta, Inc. device recall (Cls II)
December 10, 2025updated 3mo ago
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MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) — Reason: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice — Status: Ongoing
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