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InfiMed Digital Imaging System, Precision MPi, RF, CCD Camera

VAREX IMAGING CORPORATION · Model Precision MPi RF · UDI-DI 00854344007108

OWB JAA Prescription

510(k) clearances

50,677

Adverse events (108 deaths)

637

Recalls

126

Facilities

Recalls

Date	Firm	Reason
2026-10-12	Canon Medical System, USA, INC.	Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
2026-10-12	Canon Medical System, USA, INC.	Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
2026-10-12	Canon Medical System, USA, INC.	Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which
2026-10-06	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which

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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.