FDASeptember 14, 2020device

Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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