China NMPA Product Recall - SMART electrode pads for infants and children attached to semi-automatic external defibrillators

On September 7, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Philips (China) Investment Co., Ltd. This action stems from an internal monitoring discovery regarding specific M5072A infant/pediatric SMART electrode pads, an accessory for their semi-automatic external defibrillators.

The core issue involves certain M5072A electrode pad cases, specifically batch number Y111220-01, where the inner protective cover displayed incorrect images. These images, designed to illustrate proper electrode pad placement for infants or children, erroneously depicted adult chest pad positioning. While the outer packaging correctly showed infant/pediatric placement, this internal discrepancy presents a critical risk.

Philips identified that this visual inaccuracy could cause significant treatment delays during emergencies, consequently reducing the likelihood of successful resuscitation for infants and children in need of defibrillation. To address this safety concern, Philips (China) Investment Co., Ltd. is voluntarily recalling the affected infant/pediatric SMART electrode pads (Registration Certificate No.: 20183211860) to prevent potential patient harm. The NMPA's publication serves to inform the public and healthcare professionals about this crucial safety measure.