Recall Z-2392-2023— Canon Medical System, USA, INC.

Name: FDA recall Z-2392-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-22

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2023-06-22. It names one FDA 510(k) clearance: K210900. Product: INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE. Reason: The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-22
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation·cleared 2021-04-12

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-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

Reason for recall

The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

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