FDA recall Z-1175-2021
Canon Medical System, USA, INC. · Class II · device
Product
System INFX-8000C
Reason for recall
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Distribution
Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2021-02-05
- Report date
- 2021-03-17
- Voluntary/Mandated
- FDA Mandated
- Location
- Tustin, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2021