FDA Medical devices recall ·
Alphenix INFX-8000C/B5 recall
- Recall number
- Z-0108-2027
- Date
- (initiated August 26, 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
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Alphenix INFX-8000C/B5
Why was it recalled?
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
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
Serial no. B5F2532011/UDI: 4987670100192
Distribution
US Nationwide distribution in the state of ID.
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-0108-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.