The FDA has posted 12 enforcement recalls of medical linear accelerator devices since 2025, none of them Class I (most serious). Most recent report: Jul 8, 2026.
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.…
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect…
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
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.