FDA Medical devices recall ·
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM recall
- Recall number
- Z-0291-2027
- Date
- (initiated October 12, 2026)
- Company / brand
- Canon Medical System, USA, INC.
2441 Michelle Dr, Tustin, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 31 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DI-04987670100222/
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.
States: Alabama Arkansas Arizona California Florida Georgia Hawaii Illinois Louisiana Massachusetts Michigan Minnesota Mississippi North Carolina Nevada Ohio Oregon Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0291-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.