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Philips Azurion Interventional Fluoroscopic X-ray System ... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – potential loss of imaging (x-ray) fun... (2024)

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Moderate

FDAJul 15, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Moderate

FDAJul 15, 2024Nationwide

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Philips Azurion Interventional Fluoroscopic X-ray System ... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – potential loss of imaging (x-ray) fun... (2024)

Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

25GA Valved Entry System (Alcon) – Sharpness Complaint (2024)

Total Plus Valve (Alcon) – Sharpness Complaint (2024)

25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

Total Plus Valve (Alcon) – Sharpness Complaint (2024)

20 Gauge V-Lance Knife (Alcon) – Sharpness Complaint (2024)

ClearCut Sideport Knife (Alcon) – Sharpness Complaint (2024)

Total Plus Valve (Alcon) – Sharpness Complaint (2024)

25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalo... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

A-OK 19G V-Lance (Alcon) – Sharpness Complaint (2024)

25+ CMB Pak (Alcon) – Sharpness Complaint (2024)

TiBrid Fusion Device (Unknown) – Instrument Failure (2024)

Alcon Custom Pak (Alcon) – Sharpness Complaint (2024)

Collagen Joint Support (Quantum Fulfillment) – Undeclared Fish (2024)

Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)

Ion Endoluminal System (Intuitive Surgical) – Arm Screw Risk (2024)