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IntelliVue Patient Monitor (Philips) – ECG Capability Configuration (2023)

Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.

Moderate

FDAJun 14, 2023Nationwide• Philips North America Llc

Simplexa Amplification Disc Kit (DiaSorin) – Potential Malfunction (2023)

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

Moderate

FDAJun 14, 2023Nationwide• DiaSorin Molecular LLC

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IntelliVue Patient Monitor (Philips) – ECG Capability Configuration (2023)

Simplexa Amplification Disc Kit (DiaSorin) – Potential Malfunction (2023)

Impella 2.5 Pump (Abiomed) – Motor Housing Interaction (2023)

Impella CP Pump (Abiomed) – Motor Housing Interaction (2023)

Impella CP with SmartAssist (Abiomed) – Motor Housing Interaction (2023)

Impella 5.5 with SmartAssist (Abiomed) – Motor Housing Interaction (2023)

Impella LD Pump (Abiomed) – Motor Housing Interaction (2023)

Stryker Infinity Alignment Frame (Wright Medical) – Pin Sleeve Hole Defect (2023)

Durepair Dura Matrix (Medtronic) – Endotoxin Level Concern (2023)

RX Series Urea Enzymatic Assay (Randox) – Carryover Bias (2023)

Ingenia Elition X MR System (Philips) – Smoke Detector Bypass (2023)

Oxylog 3000 Plus Ventilator (Draeger) – Power Transition Failure (2023)

AEQUALIS FLEX REVIVE Screw (Tornier) – Labeling Mix-up (2023)

da Vinci Grasper (Intuitive Surgical) – Grip Breakage Risk (2023)

Ingenia Elition S MR System (Philips) – Smoke Detector Cable Issue (2023)

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Bypass (2023)

Amplatzer Steerable Delivery Sheath (Abbott) – Air Embolism Risk (2023)

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

Ingenia Elition X MR System (Philips) – Smoke Detector Cable Issue (2023)

Azurion 7 X-ray System (Philips) – FlexMove Carriage Defect (2023)