The FDA has posted 7 enforcement recalls of medical linear accelerator devices since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment an…
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console.…
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console.…
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Due to a manufacturing issue and electrical grounding of systems.
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 trea…
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Accelerator, Linear, Medical”). Informational only — verify against the FDA before acting.