Generic Name: Surgical Light — Trade Name: (1) Tromp Surgical Light Iled7 Series — (2) Iled7 Surgical Light
- Recalling firm
- Name of Manufacturer/Distributor: Central Uni Co., Ltd. — Address of Manufacturer/Distributor: 1-1 Maigaoka 5-chome, Kokuraminami-ku, Kitakyushu City, Fukuoka Prefecture — License Type: Type II...
- Product
- Lot: （１）トルンプ無影灯 iLED7シリーズ 機体番号：105571598、107366823、107366829、107366830、107366832、107366834 107366835、107368063、107368065、107388816、107392357、107396205 107401783、107403256、107410859、107429479、107438986、107440333 107440336、107466185、107468134、107515381、107517211、107521035 107521040、107521042、107521043、107589436、107589437、107589440 107589443、107589445、107589707、107589720、107593265、107593266 107596469、107596470、107596471、107596473、107596474、107596475 107601046、107630541、107630592、107659058、107663486、107666026 107669928、107689911、107739241、107768180、107768186、107770727...
- Reason
- We have received a report from the overseas manufacturer stating: “It has been determined that setting multiple shadowless lamps to high-intensity mode (80% or higher) and operating them for extended periods increases the risk of burns. Burns include skin burns and tissue desiccation, and it cannot be ruled out that they may lead to wounds, infections, or internal organ damage.” Furthermore, the overseas manufacturer has decided to implement a software update to the remote control panel that displays a warning message to make the risk of burns easily recognizable. Consequently, as the...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/83abaae5-d220-4476-b3d2-a27afc40f19d