Home / Recalls / Philips North America, LLC / Z-0285-2021

Z-0285-2021 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
November 4, 2020
Initiation Date
September 14, 2020
Termination Date
September 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,202

Product Description

Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - 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 intentionally stop start the heartbeat during cardiopulmonary surgery.

Reason for Recall

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.

Distribution Pattern

Global Distribution. US Nationwide.

Code Information

All units manufactured and distributed January 2015 to August 2020.

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