Pedi-Padz Reduced Energy Electrode, Model # 8900-0401 의 안전성 경고

Safety alert

2012-02-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120209.html

Field safety notice: zoll pedi-padz reduced energy electrode, model # 8900-0401 health canada, has issued a type ii recall on pedi-padz reduced energy electrode, model # 8900-0401, manufactured by zoll medical corporation. according to the manufacturer, the products are being recalled because a problem was identified through the supplier’s internal quality system on a production lot. the issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation. the affected lot numbers were from 0511 to 4511. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.