Home › S.I.T. SORDINA IORT TECHNOLOGIES SPA › NOVAC11

NOVAC11

S.I.T. SORDINA IORT TECHNOLOGIES SPA · Model 10 MeV · UDI-DI 08057014730487

IYE Prescription

510(k) clearances

3,068

Adverse events (20 deaths)

562

Recalls

115

Facilities

Description

The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues. The NOVAC 11 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.