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TrackX Technology, LLC · Model INSIGHT™ ARRAY-VIOLET · UDI-DI 00857088008714

OWB Prescription

510(k) clearances

50,353

Adverse events (108 deaths)

625

Recalls

125

Facilities

Description

The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.

Recalls

Date	Firm	Reason
2026-08-26	Canon Medical System, USA, INC.	Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio
2026-08-04	Canon Medical System, USA, INC.	Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
2026-07-16	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropr
2026-07-16	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications an
2026-06-29	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Firmware issue potentially leading to loss of geometry movements.
2026-06-17	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-17	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-17	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-11	Oxos Medical Inc	Due to a defective circuit board that overheats
2026-06-08	Siemens Medical Solutions USA, Inc	Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradual

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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.