Canon Medical System, USA, INC.: Medical Device Recall in 2023 - (Recall #: Z-2392-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 22, 2023

Date Posted: August 16, 2023

Recall Number: Z-2392-2023

Event ID: 92664

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.

Status: Ongoing

Product Quantity: 12

Code Information:

UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003

Distribution Pattern:

US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA

Voluntary or Mandated:

Voluntary: Firm initiated