Generic Name: Stationary Digital General-purpose X-ray Fluoroscopy System — Trade Name: X-ray Fluoroscopy System Sonialvision G4
- Recalling firm
- Name of Manufacturer and Distributor: Shimadzu Corporation — Address of Manufacturer and Distributor: 1 Nishinokyo Kuwabara-cho, Nakagyo-ku, Kyoto City, Kyoto Prefecture — Type of License: Class I...
- Product
- Lot: 製造番号：41C3502EC001,41C35078C001,41C350886001,41C3508DB001,41C3508E9002,41C3508E9003,41C3508E9004 41C3508EA002,41C3508EA003,41C3508F1001,41C3508F3001,41C3508F3002,41C3508F3003,41C3508F4001 41C3508F4002,41C351CEA001,41C351DF5001,41C3526F1001,41C353DB7002,41C353DB7003,41C353DDC001 41C353DE6002,41C353DE7001,41C353DE7002,41C353DE7008,41C353DE8005,41C353DEB001,41C353DF1003 41C353DF1004,41C353DF2001,41C353DF2002,41C353DF2003,41C353DF2004,41C353DF2005,41C353DF2006 41C353DF3001,41C353DF3002,41C355BF4001 製造時期：平成30年8月〜令和7年5月 出荷台数：38台. Use: 透視・撮影を目的とし、人体を透過したX線の電離作用を利用して人体画像情報を診断のために提供します。...
- Reason
- During design verification following an internal design change, it was discovered that when using the Smart FOV option (*) on a device equipped with this feature in a specific X-ray imaging mode, the positioning range and the range of the image obtained during X-ray imaging may differ if imaging is performed after positioning via fluoroscopy. Therefore, we will implement a software update as a voluntary corrective action. *A feature that allows the field of view to be moved without moving the table top.
- 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/981015e8-3636-41cb-aa2f-c5e23513c33e