PlainRecalls
FDA Devices Moderate Class II Ongoing

System INFX-8000F

Reported: March 17, 2021 Initiated: February 5, 2021 #Z-1176-2021

Product Description

System INFX-8000F

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.

Details

Units Affected
272 in total
Distribution
Nationwide
Location
Tustin, CA

Frequently Asked Questions

What product was recalled?
System INFX-8000F. Recalled by Canon Medical System, USA, INC.. Units affected: 272 in total.
Why was this product recalled?
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1176-2021.