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LIAC

S.I.T. SORDINA IORT TECHNOLOGIES SPA · Model 10 MeV · UDI-DI 08057014730050

IYE Prescription

510(k) clearances

3,068

Adverse events (20 deaths)

562

Recalls

115

Facilities

Description

LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia. The device may solely be used for oncological radiation therapy. The contraindications are related to use on non-oncological patients. To this end, the mobile structure with its equipment is moved to the patient at the appropriate time and placed in a position such that the applicator can be connected. At this point, the operating theatre is evacuated and the radiation command given from the console outside, after which the mobile structure is removed and surgery completed. The radiation time is normally not more than two minutes and therefore does not significantly affect the surgery time. The machine may only be used by radiation therapy or surgery staff previously trained for its use. In order to reduce the dose to the healthy tissues of the patient during the therapeutic treatment, the specific Abdominal Radiation Protection Screens must be used. The control console normally does not require sterilization but only regular cleaning. LIAC is intended to be used in a public and private health environment. LIAC is intended to be handled by trained personnel (operators)authorised by the user (authority responsible).

Recalls

Date	Firm	Reason
2026-06-16	Accuray Incorporated	In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i
2026-06-16	Accuray Incorporated	In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i
2026-05-21	Elekta, Inc.	Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
2025-12-14	Elekta, Inc.	Due to a manufacturing issue and electrical grounding of systems.
2025-12-10	Elekta, Inc.	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 l
2025-10-09	C-RAD POSITIONING AB	Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the
2025-09-17	ELEKTA SOLUTIONS AB	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.
2025-07-25	Zap Surgical Systems	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 automat
2025-04-22	C-RAD POSITIONING AB	Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
2025-04-01	IBA Dosimetry GmbH	Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.