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Ingenia Elition S 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

Oxylog 3000 Plus Ventilator (Draeger) – Power Transition Failure (2023)

Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.

Moderate

FDAJun 12, 2023Nationwide• Draeger Medical, Inc.

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

Oxylog 3000 Plus Ventilator (Draeger) – Power Transition Failure (2023)

da Vinci Grasper (Intuitive Surgical) – Grip Breakage Risk (2023)

Allura Xper X-ray System (Philips) – FlexMove Carriage Defect (2023)

AEQUALIS FLEX REVIVE Screw (Tornier) – Labeling Mix-up (2023)

Azurion 7 X-ray System (Philips) – FlexMove Carriage Defect (2023)

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

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

Amplatzer Steerable Delivery Sheath (Abbott) – Air Embolism Risk (2023)

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

Sterile Ultrasound Gel (Turkuaz) – Sterility Concern (2023)

EVIS EXERA III Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

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

Option Elite Retrievable Filter (Argon Medical) – Potential Embolism Risk (2023)

EVIS EXERA Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

EVIS EXERA II Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

BD Synapsys Informatics Solution (Becton Dickinson) – Patient Data Mis-association (2023)

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

HF Resection Electrodes (Olympus) – Wire Breakage Caution (2023)