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Water Bottle (Electro Medical Systems) – Bottle Collar Separation (2024)

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Moderate

FDAMar 13, 2024Nationwide• Electro Medical Systems SA Chemin De La Vuarpilliere

Intera 0.5T Standard (Philips) – Floor Plate Installation Error (2024)

Patient support table floor plate may be incorrectly installed.

Moderate

FDAMar 12, 2024Nationwide• Philips North America Llc

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Water Bottle (Electro Medical Systems) – Bottle Collar Separation (2024)

Intera 0.5T Standard (Philips) – Floor Plate Installation Error (2024)

Intera CV (Philips) – Floor Plate Installation Error (2024)

Intera 1.5T Master/Nova (Philips) – Floor Plate Installation Error (2024)

ATTUNE AFFIXIUM Knee (DePuy) – Incorrect Labeling (2024)

GYROSCAN T5 (Philips) – Floor Plate Installation Error (2024)

Intera 1.0T Omni/Stellar (Philips) – Floor Plate Installation Error (2024)

Intera 1.5T Achieva IT Nova (Philips) – Floor Plate Installation Error (2024)

Intera 1.5T (Philips) – Floor Plate Installation Error (2024)

GYROSCAN ACS-NT (Philips) – Floor Plate Installation Error (2024)

Namic Fluid Delivery Set (Medline) – Sterility Assurance (2024)

Achieva 1.5T Initial (Philips) – Floor Plate Installation Error (2024)

Intera Achieva 1.5T Pulsar (Philips) – Floor Plate Installation Error (2024)

GYROSCAN T10-NT (Philips) – Floor Plate Installation Error (2024)

Intera 3.0T Quasar Dual (Philips) – Floor Plate Installation Error (2024)

Evolution Upgrade 3.0T (Philips) – Floor Plate Installation Error (2024)

Intera 1.5T Power/Pulsar (Philips) – Floor Plate Installation Error (2024)

Ingenia 3.0T (Philips) – Floor Plate Installation Error (2024)

Ingenia 3.0T CX (Philips) – Floor Plate Installation Error (2024)

Ingenia Ambition X (Philips) – Floor Plate Installation Error (2024)