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

Medical device components were marketed without FDA clearance and without FDA approval

FDAMay 30, 2023Nationwide• Synovo Production

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

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

Moderate

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

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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)

VISERA Tracheal Intubation Videoscope (Olympus) – Reprocessing Compatibility (2023)

Abiomed Introducer Set (Abiomed) – Sidearm Detachment Risk (2023)

Olympus Endoscope Reprocessor (Olympus) – Reprocessing Compatibility (2023)

Flexi-Set Endotracheal Tube (TELEFLEX) – Connector Disconnection (2023)

Preformed AGT Oral Tube (TELEFLEX) – Connector Disconnection (2023)

Slick Set Cuffed Tube (TELEFLEX) – Connector Disconnection (2023)

RUSCHELIT Tracheal Tube (TELEFLEX) – Connector Disconnection (2023)

Slick Set Uncuffed Tube (TELEFLEX) – Connector Disconnection (2023)

Flexiva Pulse ID 242 TracTip single Use Fiber-intended to... (Boston Scientific Corporation) – burn hazard (2023)