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Veran Thoracic Navigation System (Olympus) – Device Nonconformance (2023)

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

PDS II Suture (Ethicon) – Tensile Strength Failure (2023)

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Moderate

FDAAug 10, 2023Nationwide

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Veran Thoracic Navigation System (Olympus) – Device Nonconformance (2023)

PDS II Suture (Ethicon) – Tensile Strength Failure (2023)

PDS Plus Antibacterial Suture (Ethicon) – Tensile Strength Failure (2023)

Welch Allyn Connex Monitor (Baxter) – Display Tape Placement (2023)

McGrath Mac Laryngoscope Blade (Covidien) – Anti-Fog Coating Issue (2023)

Veran Percutaneous Biopsy Kit (Olympus) – Navigation System Issue (2023)

Veran Endobronchial Needle (Olympus) – Navigation System Problem (2023)

Arrow Pressure Injectable CVC (Arrow) – Product Label Mismatch (2023)

Arrow ErgoPack (Arrow) – Product Label Mismatch (2023)

Veran Percutaneous Track Device (Olympus) – Navigation System Nonconformance (2023)

Bard Marquee Biopsy Kit (Bard) – Needle Diameter Mismatch (2023)

Veran Endobronchial Access Catheter (Olympus) – Navigation System Problem (2023)

Functional MR Software (Olea Medical) – Export Error (2023)

Guardian 2 System (Turncare) – Battery Alert Software (2023)

Epiphany Cardio Server (Baxter) – Software Correction (2023)

Arrow ErgoPack PICC (Arrow) – Product Label Mismatch (2023)

VITROS Chemistry Proboscis Assembly (Ortho-Clinical) – Manufacturing Issue (2023)

FluidShield N95 Respirator (Halyard) – Filtration Efficiency Failure (2023)

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

FX Shoulder Glenosphere (FX Shoulder) – Component Mismatch (2023)