Recall Z-1666-2022— Canon Medical System, USA, INC.

Name: FDA recall Z-1666-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-31

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2022-01-31. It names one FDA 510(k) clearance: K170909. Product: INFX-8000V. For radiographic and fluoroscopic studies and intervention.. Reason: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-31
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

INFX-8000V. For radiographic and fluoroscopic studies and intervention.

Reason for recall

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

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