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

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

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

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Moderate

FDAJun 12, 2023Nationwide• Intuitive Surgical, Inc.

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

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

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

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

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

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

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

OES Bronchofiberscope (Olympus) – Endobronchial Combustion Risk (2023)

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

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

Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

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

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

BeamAdjust Software (PTW-FREIBURG) – Calibration File Error (2023)

FRED Flow Re-Direction Endoluminal Device (MICROVENTION) – Incorrect Inner Stent Length (2023)

NanoZoomer S360MD Slide Scanner (Hamamatsu) – Incorrect Barcode Identification (2023)

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

Vios Bedside Monitor (Murata Vios) – Pulse Oximeter Sensor Failure (2023)

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

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