Generic Name: Treatment Electrode — Brand Name: Megasoft Plus

Recalling firm: Name of Manufacturer and Distributor: Johnson & Johnson K.K. — Address of Manufacturer and Distributor: 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo — License Type: Class I Medical Device Manufacturer and...
Product: Lot: 製品番号：0847 対象シリアル（ロット）： GS23028201, GS23034401, GS23034404, GS23044301, GS23044303, GS23047501, GS23047502, GS23047503, GS23 047504, GS23047505, GS23051502, GS24003501, GS24009401, GS24016501, GS24017801, GS24018701, GS240194 01, GS24019402, GS24019403, GS24029701, GS24029702, GS24036601, GS24036602, GS24038301, GS24038302, GS24041201 製品番号：0848 対象シリアル（ロット）： GS23034602, GS23034603, GS24038601 対象数量：29個出荷時期：令和5年7月26日〜令和6年12月5日. Use: モノポーラの装着部をもつ電気手術器において、アクティブ電極から出る高周波電流は、患者の体を通り対極板を経て電気手術器本体に戻る。本品は、モノポーラの装着部をもつ電気手術器を使用する際、高周波電流を回収するために用いる容量結合型対極板である。. Health hazards:...
Reason: We received reports of burns occurring in multiple cases where this product was used on children overseas. Following an investigation by the overseas manufacturer, it was determined that the risk of burns cannot be completely ruled out when multiple specific conditions coincide. Since the likelihood of these specific conditions coinciding is high among children, including newborns and infants, we have issued a safety advisory to change the product’s intended use from “0.35 kg or more” to “12 years of age or older.” However, as this product is labeled for use in patients weighing 0.35 kg or...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/d96539dd-5237-4271-9ed9-c5facf95e24c