Recall Z-1174-2021— Canon Medical System, USA, INC.

Name: FDA recall Z-1174-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-05

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2021-02-05. It names one FDA 510(k) clearance: K170909. Product: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2021-02-05
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170909 — Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation·cleared 2017-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.