Z-1174-2021 Class II Ongoing
FDA device recall Z-1174-2021 was initiated by Canon Medical System, USA, INC. on February 5, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 272 in total.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- February 5, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 272 in total
Product Description
System INFX-8000V
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 Pattern
Nationwide
Code Information
Model: CAS-880A, CAS-830B