FDA Enforcement
Class II
Ongoing
System INFX-8000V
Recall: Z-1174-2021
·
Reported March 17, 2021
Enforcement
- Recall Number
- Z-1174-2021
- Event ID
- 87419
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Canon Medical System, USA, INC.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- March 17, 2021
- Initiation Date
- February 5, 2021
- Classification Date
- March 9, 2021
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
System INFX-8000V
Reason
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Code Info
Model: CAS-880A, CAS-830B
Distribution
Nationwide
Quantity
272 in total