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LIFEPAK 15 Masimo Sensors (Physio-Control) – sensor error (2025)

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

Moderate

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

Low

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

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LIFEPAK 15 Masimo Sensors (Physio-Control) – sensor error (2025)

LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)

A.L.P.S. Medial Tibia Plate (Tyber) – screw placement risk (2025)

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