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BodyFIX

3C-Medical Intelligence GmbH · Model P10102-413 · UDI-DI 04056719000332

IYE Prescription

510(k) clearances

3,073

Adverse events (20 deaths)

562

Recalls

115

Facilities

Description

BodyFIX® Indexing Adapter P2 is used for attaching the BodyFIX base plate to indexed tabletops provided by other manufacturers. This is required for using the BodyFIX System on other tabletops. The delivery set of the BodyFIX® Indexing Adapter P2 contains three indexing adapters.

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.