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Ingenia Elition X MR System (Philips) – Smoke Detector Cable Issue (2023)

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

Moderate

FDAJun 12, 2023Nationwide

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Ingenia Elition X MR System (Philips) – Smoke Detector Cable Issue (2023)

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

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Bronchovideoscope BF Type (Olympus) – Endobronchial Combustion Risk (2023)

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OmniTom X-ray CT System (NeuroLogica) – Device Mobility Risks (2023)

Vanta AdaptiveStim Neurostimulator (Medtronic) – Cardioversion Damage (2023)

Catalyft LS Interbody System (Medtronic) – Geometry Specification Issue (2023)