Generic Name: Floor-standing Digital Cardiovascular Fluoroscopy System Trade Name: (1) Alphenix Infx-8000c Cardiovascular Diagnostic System (2) X-ray Cardiovascular Diagnostic System Alphenix Infx-8000v
Recall Summary Two Alphenix X-ray diagnostic systems used for imaging blood vessels have been recalled because bolts securing the movable top panel may have loosened during manufacturing, potentially causing the panel to become difficult to move or stop working altogether. The affected units are serial numbers TJB2532004 and T7D2542029, manufactured by Canon Medical Systems. No injuries have been reported, and the panel will not detach even if it malfunctions.
- Recalling firm
- Name of Manufacturer/Distributor: Canon Medical Systems Corporation Address of Manufacturer/Distributor: 1385 Shimoishigami, Otawara City, Tochigi Prefecture Type of License: Class I Medical...
- Product
- Lot: (1)形式名 : INFX-8000C Ser.No : TJB2532004 数量 ：1台 出荷時期：令和7年 3月 (2)形式名 : INFX-8000V Ser.No : T7D2542029 数量 ：1台 出荷時期：令和7年 4月. Use: Ｘ線を利用して人体を検査または診断する手段を提供する装置で、医師もしくは診療放射線技師等有資格者が 使用します。. Health hazards: 本事象により、天板の操作に支障をきたし、最悪の場合は、天板の動作が不能となる可能性がありますが、構 造的に天板が外れることは無いので、重篤な健康被害が発生する可能性はないと考えています。 なお、これまでに本事象による健康被害発生の報告は受けておりません。
- Reason
- It has been determined that, in the catheter table included in the X-ray cardiovascular diagnostic system, bolts securing the longitudinal guide rails of the table top may become loose due to deficiencies in factory work procedures. In this case, it has been determined that the tabletop may become loose, making manual operation of the tabletop difficult and, in the worst-case scenario, potentially rendering the system inoperable. However, even if this issue occurs, the tabletop will not detach due to the system’s structural design.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-03-11
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d2132a02-43b3-4403-b90b-c60b29310b0d