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Dynamic Coronary Roadmap

Philips Medical Systems Nederland B.V. · Model Dynamic Coronary Roadmap - 3 · UDI-DI 00884838101883

OWBLLZ Prescription
10
510(k) clearances
50,677
Adverse events (108 deaths)
637
Recalls
126
Facilities

Description

Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

Recalls

DateFirmReason
2026-10-12Canon 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.
2026-10-12Canon 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.
2026-10-12Canon 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.
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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
2026-10-06PHILIPS 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.