Z-0108-2027 Class II Ongoing
FDA device recall Z-0108-2027 was initiated by Canon Medical System, USA, INC. on Aug 26, 2026 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Aug 26, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Alphenix INFX-8000C/B5
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the state of ID.
Code Information
Serial no. B5F2532011/UDI: 4987670100192
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0108-2027
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026