Generic Name: Mobile Digital General-purpose Integrated X-ray Fluoroscopy System — Trade Names: (1) Corevision 3d X-ray Fluoroscopy System — (2) Corevision Ld X-ray Fluoroscopy System — (3) Corevision Sd X-ray Fluoroscopy System
- Recalling firm
- Name of Manufacturer and Distributor: Fujifilm Corporation — Address of Manufacturer and Distributor: 798 Miyadai, Kaisei-machi, Ashigarakami-gun, Kanagawa Prefecture — Type of License: Class I...
- Product
- Lot: (1) X線透視診断装置 CoreVision 3D 製造番号： 28000, 28002, 28014, 28018, 28019, 28021, 28023, 28024, 28026, 28029, 28031, 28032, 28033, 28034, 28035, 28037, 28039, 28041, 28042, 28045, 28046, 28048, 28049, 28051, 28060, 28064, 28068, 28069, 28073, 28074, 28075, 28078, 28079, 28080, 28081, 28082, 28087, 28089, 28090, 28092, 28094, 28096, 28103, 28107, 28108, 28109, 28110, 28111, 28112, 28113, 28114, 28118, 28121, 28123, 28125, 28126, 28127, 28128, 28129, 28130 数量：60台 出荷時期：平成30年9月〜令和7年3月 (2) X線透視診断装置 CoreVision LD 製造番号： 28006, 28007, 28009, 28010, 28011, 28012, 28015, 28017, 28020, 28022, 28025,...
- Reason
- Due to inadequate instructions regarding the replacement of the power plug, the plug was not replaced properly, resulting in smoke emission and the need to use an alternative medical device during surgery. Since smoke emission or a broken wire caused by a short circuit inside the power plug could render the device inoperable and affect the surgery, we are conducting a voluntary recall to replace the power plug.
- 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/bcc26042-fd00-44a8-b86f-5e572a847a92