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iQ Waste Well Adapter (Beckman Coulter) – Cannula Rust Risk (2023)

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

Moderate

FDADec 19, 2023Nationwide• Beckman Coulter, Inc.

PulseSpray Infusion System (Angiodynamics) – O-Ring Seal Defect (2023)

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

High

FDADec 18, 2023Nationwide• Angiodynamics, Inc.

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iQ Waste Well Adapter (Beckman Coulter) – Cannula Rust Risk (2023)

PulseSpray Infusion System (Angiodynamics) – O-Ring Seal Defect (2023)

TactiFlex Ablation Catheter (St. Jude) – System Recognition Issue (2023)

BrightView Gamma Camera (Philips) – Detector Fall Risk (2023)

ESG PK Cutting Forceps (Olympus) – Jaw Fracture Risk (2023)

BrightView XCT Gamma Camera (Philips) – Detector Fall Risk (2023)

Panther Fusion System (Hologic) – False Flu B Result (2023)

IgM Total Test (Siemens) – Potential Negative Bias (2023)

ProxiDiagnost N90 (Philips) – Mixed Patient Images (2023)

BrightView X Gamma Camera (Philips) – Detector Fall Risk (2023)

ExcelsiusGPS Cannula (Globus) – Sterility Concern (2023)

ProxiDiagnost Upgrade (Philips) – Mixed Patient Images (2023)

Pneumonia Panel (BioFire) – False Positive Risk (2023)

Pneumonia Panel Plus (BioFire) – False Positive Risk (2023)

Express Chest Drain (Maquet) – Sterile Water Syringe Risk (2023)

LIAISON HSV-2 IgG Test (Diasorin) – Lot Number Concern (2023)

Express Single Chest Drain (Maquet) – Sterile Water Syringe Risk (2023)

Spectral CT 7500 (Philips) – Image Labeling Error (2023)

Sedecal X Optima URS X-Ray (Sedecal) – Equipment Part Failure (2023)

Spectral CT on Rails (Philips) – Image Labeling Error (2023)