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Phoroptor VRX System (Reichert) – Head Detachment Risk (2023)

Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator

Moderate

FDAJul 20, 2023Nationwide• Reichert, Inc.

Neurosurgical Trocar (Aesculap) – Manufacturing Length Issue (2023)

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured.

Moderate

FDAJul 20, 2023Nationwide• Aesculap Implant Systems LLC

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Phoroptor VRX System (Reichert) – Head Detachment Risk (2023)

Neurosurgical Trocar (Aesculap) – Manufacturing Length Issue (2023)

Visera Hysterovideoscope (Olympus) – Labeling Update (2023)

Cosmedent FlexiCup (Cosmedent) – Material Crumbling (2023)

Zenition 70 (Philips) – Radiation Exposure Risk (2023)

NOxBOXi System (NOxBOX) – Sample Pump Replacement (2023)

Azurion (Philips) – Unintended Radiation Emission (2023)

Allura Xper Series (Philips) – Unintended Radiation Emission (2023)

Freedom Boom Models (IHB) – Suspension Arm Weakness (2023)

MultiDiagnost-Eleva (Philips) – Unintended Radiation Emission (2023)

Randox Liquid Protein Calibrator (Randox) – Ferritin Restandardization (2023)

Neodent Healing Abutment (Preat) – Dimensional Gap Risk (2023)

Portex Hydrophobic Filter (Smiths Medical) – Labeling Error (2023)

Proclaim Plus 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Proclaim XR 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Proclaim XR 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Proclaim Plus 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Infinity 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Infinity 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Proclaim DRG Pulse Generator (Abbott) – MRI Mode Malfunction (2023)