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Trexo Device (Trexo Robotics) – Electrical Functionality Risks (2023)

Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

High

FDAMay 31, 2023Nationwide• Trexo Robotics Holdings Inc.

Profile 0 AutoDrive Screw (Osteomed) – Screwhead Size Risk (2023)

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Moderate

FDAMay 31, 2023Nationwide• Osteomed, LLC

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Trexo Device (Trexo Robotics) – Electrical Functionality Risks (2023)

Profile 0 AutoDrive Screw (Osteomed) – Screwhead Size Risk (2023)

Haemophilus Test Medium (Remel) – Performance Uncertainty (2023)

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

MICRO-X Rover Mobile X-ray System (Micro-X) – Exposure Time Limitation (2023)

Profile Zero Auto-Drive Screw (Osteomed) – Screwhead Size Risk (2023)

COULTER DxH Diluent (Beckman Coulter) – Specification Deviation (2023)

Prima TT Genoid Monoblock Baseplate (Limacorporate) – Hole Specification Issue (2023)

VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

Acetabular Fixation Cup (Synovo) – FDA Approval Missing (2023)

GE Vivid S60N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE Vivid S70 Ultrasound (GE Vingmed) – System Boot Delay (2023)

Prima TT Genoid Baseplate (Limacorporate) – Hole Specification Issue (2023)

Acetabular Bearing (Synovo) – FDA Clearance Concern (2023)

Femoral Resurfacing Cup (Synovo) – FDA Clearance Concern (2023)

Custom Medical Procedure Packs (DeRoyal) – Package Seal Compromise (2023)

Alinity ci-series Control Module (Abbott) – System Performance Issues (2023)

GE Vivid S60 Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE Vivid S70N Ultrasound (GE Vingmed) – System Boot Delay (2023)

Tracheal Intubation Fiberscope (Olympus) – Reprocessing Compatibility (2023)