Device recall
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
- Recall number
- Z-0289-2027
- Event id
- 99889
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Report date
- Nov 4, 2026
- Posted
- Oct 27, 2026
- Initiated
- Oct 12, 2026
- Center classification date
- Oct 27, 2026
- Product code
- OWB
- Device type
- Interventional Fluoroscopic X-Ray System
- Reason
- Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
- Root cause
- Software design
- Quantity
- 15 SYSTEMS
- Code info
- DI-04987670100192
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, LA, MA, MI, MN, MS, NC, NV, OH, OR, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K210900
- Location
- Tustin, CA, United States