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Incisive CT Brazil (Philips) – Mounting Box Risk (2023)

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

Moderate

FDAApr 25, 2023Nationwide• Philips North America

SteriPack Swabs (LumiraDx) – Breakage Risk (2023)

Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab

Moderate

FDAApr 25, 2023Nationwide• LumiraDx

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Incisive CT Brazil (Philips) – Mounting Box Risk (2023)

SteriPack Swabs (LumiraDx) – Breakage Risk (2023)

SymphoKnee Femoral Augment (Linkbio) – Incorrect Implant (2023)

Ventralight ST Ellipse (Davol) – Balloon Inflation (2023)

Incisive CT System (Philips) – Mounting Box Risk (2023)

Ventralight ST Ellipse (Davol) – Balloon Inflation (2023)

Ventralight ST Circle (Davol) – Balloon Inflation (2023)

FilmArray GI Panel (BioFire) – False Positive Risk (2023)

Incisive CT Plus (Philips) – Mounting Box Risk (2023)

Aligned Medical Solutions Hand Pack (Windstone Medical) - Handle Cover Risk (2023)

Spine Pack (Windstone) – Light Handle Detachment (2023)

Aligned Medical Solutions Minor Hand Pack (Windstone Medical) - Handle Cover Risk (2023)

Xpert Xpress Strep A (Cepheid) – Pipette Failure (2023)

Xpert Xpress Strep A (Cepheid) - Sample Volume Failure (2023)

Alinity i Anti-TPO Reagent Kit (Abbott) - Fill Volume Error (2023)

Aspira Valve Repair Kit (Merit Medical) - Valve Malfunction (2023)

Aspira Peritoneal Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Pleural Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Sterile Arthroscopy Pack (Medline) - Water Damage (2023)