Generic Name: Surgical Lighting System — Trade Names: (1) Hospilight Ledx — (2) Hospilight Ledxii — (3) Hospilight Ledxiv — (4) Mizuho Pulare Series Pulareii — (5) Mizuho Pulare Series Pulareiv
- Recalling firm
- Name of Manufacturer/Distributor: Daiichi Lighting Co., Ltd. — Address of Manufacturer/Distributor: 1-32-26 Sakashita, Itabashi-ku, Tokyo — License Type: Type III Medical Device...
- Product
- Lot: 販売名：ホスピライト LEDX 製品型式：LEDX7TV 対象台数：14台 出荷時期：2007年11月〜2010年3月 製造番号： 07110004、08060007、08060008、09020451、09070522、09070523、09070524、09070525、09070526、 09070527、09070528、10010030、10010550、10030034 販売名：ホスピライト LEDXII 製品型式：LEDXII7 対象台数：43台 出荷時期：2011年1月〜2015年6月 製造番号： 11010013、11010014、11010015、11050016、11080017、11080018、11080019、11080020、11080021、 11080022、11080023、11090024、11090025、11090026、11090027、11090028、11090029、11090030、 11090031、11110033、12010034、12010035、12010036、12010037、12010038、12060039、12060040、 12080042、12080043、12090045、12090046、12100047、12100048、12100049、12110050、12110051、...
- Reason
- Due to an incident in the U.S. market where the lamp housing of a 7-light head model fell off, the manufacturer conducted an investigation and determined that the housing frame had fractured as a result of excessive force. Although no similar incidents have occurred in the domestic market, we have determined that there is a potential risk to some of the same models sold domestically. Therefore, we are implementing a voluntary recall to replace the lamp housing frames on certain products equipped with 7-light heads.
- 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/a4021bc6-0358-4894-bdbc-334097f44678