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Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

High

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

Moderate

FDAMay 16, 2024Nationwide• BioFire Diagnostics, LLC

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Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

TourniKwik Tourniquet Set (Medtronic) – Component Placement Error (2024)

Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)

Abbott Proclaim 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Proclaim 7 Elite Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Proclaim 5 Elite Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

Inspire Model 3028 Pulse Generator (Inspire Medical) – Electrical Leakage (2024)

Abbott Proclaim Plus 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Ultrathane Cook-Cope Drainage Catheter (Cook) – Incorrect Expiration (2024)

Total Knee Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Knee Arthroscopy Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Knee Arthroscopy Pack (American Contract Systems) – EO/ECH Residuals (2024)

A610 Clinician Programmer (Medtronic) – MRI Limitation (2024)

Total Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

ACL St. Lukes Methodist (American Contract Systems) – EO/ECH Residuals (2024)

Major Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Custom Knee Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

ACL Pack (American Contract Systems) – EO/ECH Residuals (2024)