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FUJIFILM Healthcare Americas Corporation

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL · Model Persona CS · UDI-DI 08055186670372

OWB OXO Prescription

510(k) clearances

49,979

Adverse events (105 deaths)

624

Recalls

121

Facilities

Description

This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.

Recalls

Date	Firm	Reason
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
2026-05-20	Siemens Medical Solutions USA, Inc	Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

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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.